Directly interface with automotive customer quality engineers to collaborate on product quality topics
Directly interface with internal teams to address product development quality
Lead 8D investigations for quality issues and work to deploy systemic corrective actions
Create customer facing 8D reports
Assist Sales team on customer quality matters
Support customer PPAP and documentation requests
Requirements
BSEE degree
Minimum of 8 years of experience in engineering role (Quality Engineering, Product Engineering, Test Engineering, Applications Engineering) supporting or developing automotive products or processes.
Experience with AECโQ100 product qualifications
Direct Experience managing 8D investigations and creating 8D reports
Enjoys working in crossโfunctional team environment
Enjoys problem solving
Preferred
Faiure Analysis lab experience
APQP, FMEA, Control Plans experience
IATF auditor certification or experience
VDA auditor certification or experience
Project management experience
Direct customer support / facing experience
Please send us your updated Resume at ****************************** for Review.
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$119k-161k yearly est. 3d ago
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Assistant Deputy Medical Executive - Quality Management
California Correctional Health Care Services 3.5
Quality manager job in Elk Grove, CA
Ready to join an organization committed to healthcare quality improvement, patient safety, change management, and better health outcomes?
California Correctional Health Care Services' (CCHCS) Quality Management (QM) Unit and Patient Safety (PS) Program continuously evaluates and improves the performance of a complex health care system that delivers comprehensive primary care to patients within all adult correctional institutions in California.
We are seeking a self-motivated, analytical clinician with the ability to translate and communicate aspects of the clinical world to non-clinical data analysts and facilitate consensus and understanding to internal clients and external stakeholders, including other state agencies, legislative staff, oversight bodies, and various professional committees and workgroups. Experience with/understanding of tenets and applications of Lean Six Sigma as well as coding in SQL, Python, R, and CCL is highly desirable.
About the Position:
Reporting directly to the Deputy Medical Executive over the QM/PS Programs, you will
Take responsibility for the implementation of clinical informatics focused on organizational performance evaluation, patient safety surveillance, and quality improvement efforts
Support, supervise, and mentor a team of six QM/PS physicians in the use of industry standard quality improvement techniques, including conducting root cause analyses, Lean Six Sigma projects, and other projects to analyze quality problems and mitigate risk to patients and staff
Consult with staff members in performance measure development, decision support and training material design while promoting a culture of safety and positive system change
Travel to correctional institutions to engage with healthcare staff, custody staff, and incarcerated persons throughout the state will include occasional overnight trips
Benefits:
In return for your skills, we offer competitive salaries and reliable State of California benefits, including:
Generous paid time off and holiday schedule
State of California pension (visit ****************** for retirement formulas)
Comprehensive medical, dental, and vision insurance plans
Robust 401(k) and 457(b) retirement plans (tax defer up to $47,000-$62,000 per year)
And much more
Requirements:
California Medical License, with board certification in Internal Medicine, Family Medicine, or Psychiatry
Min. 5 yrs. clinical experience in a comprehensive medical setting
Min. 2 yrs. experience supervising physicians with full authority to hire, evaluate, conduct quality reviews, and responsibility for practical practice development and discipline
Experience coding in SQL, Python, R, and CCL is highly desirable
Experience with/understanding of tenets and applications of Lean Six Sigma
About California Correctional Health Services:
State of California agency partnered with the California Department of Corrections and Rehabilitation (CDCR)
Robust Correctional Health System providing medical, dental, and mental health care with headquarters in Elk Grove, multiple Regional Offices, and more than 30 CDCR facilities across California.
Take the Next Steps:
For more information, contact Erica Nuezca at ************************ or apply online using the following steps:
Create a CalCareers account here if you don't have one already and obtain Eligibility by visiting the Exam page and clicking "Apply Now."
Complete and Submit the Exam Application (include your CA license info, education, and experience) and save your application as a template for Step #3. Take the Online Exam: This is a self-rating of your skills and experience - not a knowledge-based test - which should take about 30-60 minutes of uninterrupted time to complete.
Apply for the Position: after you have taken and passed the assessment and your employment eligibility is active, use your saved application template to apply and submit your application!
EOE
$47k-62k yearly 3d ago
Senior Supplier Quality Engineer - Energy & Reliability
Bloom Energy 4.8
Quality manager job in San Jose, CA
A leading clean energy company in San Jose, CA is seeking a Senior Staff Supplier Quality Engineer to enhance quality standards for fuel cell components. The role involves assessing supplier capabilities, managing product development processes, and driving continuous improvement initiatives. Ideal candidates will have a strong background in engineering, proven project management skills, and the ability to thrive in a dynamic environment. The position offers competitive compensation and a full-time engagement.
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$105k-129k yearly est. 4d ago
Quality Manager
The Kraft Heinz Company 4.3
Quality manager job in Escalon, CA
Job Purpose
The Escalon Quality Manager is responsible for leading implementation of the Kraft Heinz Management System (KHMS) through quality and food safety leadership of multiple production lines and departments within the factory. Additionally, the Quality Manager is responsible for executing quality and food safety strategic initiatives at the manufacturing site to drive continuous improvement while delivering against all Kraft Heinz internal quality measures (KPIs), external regulatory standards, and 3rd party customer requirements. They utilize methods, tools, and procedures to deliver zero defects from incoming raw materials to outgoing finished goods in a food safe environment. This managerial position also oversees the talent and career development of their team members as a prominent member of the factory leadership team. The Quality Manager plays a key role in contributing to our vision of growing sustainably and delighting more consumers by ensuring the quality and protection of our brands. This position also plays an important role aligned with our values "we are consumer obsessed, we own it, and dare to do better every day".
Essential Functions & Responsibilities
Leads a team of Quality professionals capable of delivering on quality and production strategies.
Works with the corporate quality team and various support function to deliver on quality excellence programs to driving performance in consumer complaint reduction, hold reduction, sanitation execution, and regulatory compliance within their departmental supervision.
Utilization of industry and Kraft Heinz quality tools (RCFA, SPC, Green Belt, etc.) to improve quality and product superiority.
Leads and implements best-in-class quality and food safety KPIs to measure performance of team members, ultimately aligning with the larger factory and business priorities.
Drives team member engagement through strong leadership, career development, and conflict management.
Builds strong relationships with plant leadership team members and peers to ensure quality programs are driven through cross-functional partnerships with shared goals.
Partners with corporate team to drive automation and digital solutions including KHC Lighthouse and factory/lab of the future initiatives.
Capable of evaluating performance and competencies of team members while providing leadership training, coaching, and accountability as needed.
Drives consistency through development of work instructions and training to set standards.
Manages the quality incident root cause and corrective/preventative program within their department to drive continuous improvement and sustainable results.
Drives excellence in innovation thru supporting R&D plant trials and feedback, ensuring successful end-to-end commercialization of brand maintenance and innovation projects.
Maintains plant GMPs, HACCP, pre-requisite programs and assisting the site quality manager during external regulatory agency (FDA, USDA, CFIA, etc.) routine and unannounced visits.
Provides direction and subject matter expertise on plant Quality-related activities and inquiries.
Prepares for and participates in internal and external quality audits, ensuring all corrective and preventative action timelines are adhered to.
Routinely monitors KHC quality systems, tools, and data sources to proactively address potential risks before they occur.
Oversees record keeping within their departments for all mandated quality checks, testing, sampling and sanitation activities.
Tracks, analyzes, and supports RCFA initiatives for quality-related, factory-controllable consumer complaints.
Serves as the lead for company quality and manufacturing initiatives within their departments, including the implementation of the Kraft Heinz Management System (KHMS).
Communicates effectively across all levels of the factory and corporate leadership team.
Routine engagement with line operators to train, coach, and develop.
Expected Experience & Required Skills
Must be a self-directed individual with a high level of integrity and maturity with proven leadership skills related to coaching/development of team members.
Ability to work well under pressure through times of crisis management.
Must be an effective communicator with excellent follow-up skills and comfortable interacting with all levels of the organization.
Strong knowledge of GFSI (FSSC 22000) requirements.
Demonstrates understanding of Statistical Process Control (SPC), HACCP, sanitation, analytical/microbiology testing principles, and hygienic design principals.
Has project management skills and a working knowledge of Microsoft Word, Excel, Access and PowerPoint.
ERP system and Quality system experience, SAP and Infinity preferred.
Demonstrates the ability to drive continuous improvement, is results-driven and delivers against set targets.
Capable of fostering a strong Quality Culture that supports transformational change in line with the Kraft Heinz Company strategy.
English and Spanish language ability recommended
Work Environment & Schedule
This position is considered a
Manufacturing plant environment with heavy machinery and equipment.
Additionally, this role requires shifts, weekends, and all required overtime as needed. Fresh pack season in KHC Escalon is generally 90days (general timeframe July - Oct). Post-fresh pack season, the site continues a reduced level of pack and labeling to round out the year.
Physical Requirements
Physical demands include but not limited to
Frequent - activity or conditions sustained 1/3 to 2/3 of working hours; Upright stance, keyboard or text input; Sedentary - occasionally exerting 0 - 10 lbs. of force, limited movement from workstation for brief periods of time.
This job description is not designed to cover or contain all duties or responsibilities that are required of the role. Duties or responsibilities may change or be added with or without notice.
Our Total Rewards philosophy is to provide a meaningful and flexible spectrum of programs that equitably support our diverse workforce and their families and complement Kraft Heinz' strategy and values.
New Hire Base Salary Range:
$102,100.00 - $127,600.00
Bonus: This position is eligible for a performance-based bonus as provided by the plan terms and governing documents.
The compensation offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors
Benefits: Coverage for employees (and their eligible dependents) through affordable access to healthcare, protection, and saving for the future, we offer plans tailored to meet you and your family's needs. Coverage for benefits will be in accordance with the terms and conditions of the applicable plans and associated governing plan documents.
Wellbeing: We offer events, resources, and learning opportunities that inspire a physical, social, emotional, and financial well-being lifestyle for our employees and their families.
You'll be able to participate in a variety of benefits and wellbeing programs that may vary by role, country, region, union status, and other employment status factors, for example:
Physical - Medical, Prescription Drug, Dental, Vision, Screenings/Assessments
Social - Paid Time Off, Company Holidays, Leave of Absence, Flexible Work Arrangements, Recognition, Training
Emotional - Employee Assistance Program , Wellbeing Programs, Family Support Programs
Financial - 401k, Life, Accidental Death & Dismemberment, Disability
Location(s)
Escalon
Kraft Heinz is an Equal Opportunity Employer - Underrepresented Ethnic Minority Groups/Women/Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity and other protected classes. In order to ensure reasonable accommodation for protected individuals, applicants that require accommodation in the job application process may contact *********************** for assistance.
$102.1k-127.6k yearly Auto-Apply 60d+ ago
Quality Technical Leader
Cisco Systems Canada Co 4.8
Quality manager job in San Jose, CA
The application window is expected to close on:
Job posting may be removed earlier if the position is filled or if a sufficient number of applications are received.
The application window is expected to close on 02/23/2026 Job posting may be removed earlier if the position is filled or if a sufficient number of applications are received. This is a hybrid role with two days in the San Jose office.
Meet the Team
Our team is part of Cisco's Supply Chain Operations. You will be joining Cisco's central Quality team, which manages the company's Quality Management System (QMS), including field and factory performance for core hardware (HW) products.
We are a diverse group of quality engineers and business architects who drive business outcomes for Cisco's quality core processes. A major part of our mission is digitizing our QMS. Our team is committed to improving our Quality Management System and driving transformative improvements across the organization. We develop and execute forward-thinking strategies that leverage sophisticated analytics to deliver step-change improvements in quality and operational excellence.
Your Impact
* In this role, you will establish new processes to address evolving dynamics and quality expectations for hyperscale customers, spanning both New Product Introduction (NPI) and field-sustaining activities.
* You will act as the critical liaison between key business stakeholders-including Product Quality, Customer Quality, and Services Planning-and the Data Architecture and Data Engineering teams. Your ability to translate ambiguous problem statements into clear, actionable plans will be crucial in delivering impactful, data-driven solutions.
* Beyond solving execution-level challenges through analytics, you will lead the integration of point solutions into a cohesive, scalable, and comprehensive strategy that aligns with broader organizational goals. This position offers a unique opportunity to combine technical expertise, critical thinking, and cross-functional collaboration to deliver meaningful and transformative outcomes.
* Serve as a subject-matter expert on hardware quality metrics, including New Product Introduction (NPI), factory quality, and field quality for digital products comprising hardware, software, and cloud services.
* Develop and refine factory yield performance metrics to meet Six Sigma quality goals.
* Perform actionable data analysis to detect trends, identify root causes, and drive continuous improvement initiatives that enhance customer satisfaction.
* Capture quality requirements and data for Cisco products, providing recommendations for quality improvement and governance that will be demonstrated across multiple Cisco Business Units.
* Communicate proposals, strategies, and progress updates to Cisco executives.
* Document business requirements and analyze data to provide meaningful metrics and performance KPIs for business users.
* Coordinate research, analysis, and technical recommendations to address customer issues related to quality, reliability, and customer experience for Cisco offerings.
Minimum Requirements
* 10+ years of experience in hardware quality management for networking routers/switches. Bachelor's Degree in Engineering.
* Expertise in Quality Management Systems (QMS).
* Solid experience in root cause investigation, data analysis, and presenting findings, as well as implementing closed-loop corrective, preventive, and risk mitigation actions for executives and business partners.
* Deep understanding of hardware product quality and reliability principles, including concepts such as bathtub curves, Mean Time Between Failures (MTBF), Annualized Return Rate (ARR), and Annualized Failure Rate (AFR).
* Proficiency in SQL and data visualization platforms (e.g., Tableau, Power BI) to create compelling visual narratives and effectively communicate business insights.
Preferred Skills
* Master's Degree in Electrical Engineering.
* Strong problem-solving skills with attention to detail when working with complex datasets.
* Ability to evaluate and implement tools and technologies for scalable decision automation systems.
Why Cisco
Cisco is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, genetic information, age, disability, veteran status, or any other legally protected basis.
Cisco will consider for employment, on a case by case basis, qualified applicants with arrest and conviction records.
At Cisco, we're revolutionizing how data and infrastructure connect and protect organizations in the AI era - and beyond. We've been innovating fearlessly for 40 years to create solutions that power how humans and technology work together across the physical and digital worlds. These solutions provide customers with unparalleled security, visibility, and insights across the entire digital footprint. Simply put - we power the future.
Fueled by the depth and breadth of our technology, we experiment and create meaningful solutions. Add to that our worldwide network of doers and experts, and you'll see that the opportunities to grow and build are limitless. We work as a team, collaborating with empathy to make really big things happen on a global scale. Because our solutions are everywhere, our impact is everywhere.
We are Cisco, and our power starts with you.
Why Cisco?
At Cisco, we're revolutionizing how data and infrastructure connect and protect organizations in the AI era - and beyond. We've been innovating fearlessly for 40 years to create solutions that power how humans and technology work together across the physical and digital worlds. These solutions provide customers with unparalleled security, visibility, and insights across the entire digital footprint.
Fueled by the depth and breadth of our technology, we experiment and create meaningful solutions. Add to that our worldwide network of doers and experts, and you'll see that the opportunities to grow and build are limitless. We work as a team, collaborating with empathy to make really big things happen on a global scale. Because our solutions are everywhere, our impact is everywhere.
We are Cisco, and our power starts with you.
Message to applicants applying to work in the U.S. and/or Canada:The starting salary range posted for this position is $187,300.00 to $237,200.00 and reflects the projected salary range for new hires in this position in U.S. and/or Canada locations, not including incentive compensation*, equity, or benefits.
Individual pay is determined by the candidate's hiring location, market conditions, job-related skillset, experience, qualifications, education, certifications, and/or training. The full salary range for certain locations is listed below. For locations not listed below, the recruiter can share more details about compensation for the role in your location during the hiring process.
U.S. employees are offered benefits, subject to Cisco's plan eligibility rules, which include medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, paid parental leave, short and long-term disability coverage, and basic life insurance. Please see the Cisco careers site to discover more benefits and perks. Employees may be eligible to receive grants of Cisco restricted stock units, which vest following continued employment with Cisco for defined periods of time.
U.S. employees are eligible for paid time away as described below, subject to Cisco's policies:
10 paid holidays per full calendar year, plus 1 floating holiday for non-exempt employees
1 paid day off for employee's birthday, paid year-end holiday shutdown, and 4 paid days off for personal wellness determined by Cisco
Non-exempt employees** receive 16 days of paid vacation time per full calendar year, accrued at rate of 4.92 hours per pay period for full-time employees
Exempt employees participate in Cisco's flexible vacation time off program, which has no defined limit on how much vacation time eligible employees may use (subject to availability and some business limitations)
80 hours of sick time off provided on hire date and each January 1st thereafter, and up to 80 hours of unused sick time carried forward from one calendar year to the next
Additional paid time away may be requested to deal with critical or emergency issues for family members
Optional 10 paid days per full calendar year to volunteer
For non-sales roles, employees are also eligible to earn annual bonuses subject to Cisco's policies.
Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components, subject to the applicable Cisco plan. For quota-based incentive pay, Cisco typically pays as follows:
.75% of incentive target for each 1% of revenue attainment up to 50% of quota;
1.5% of incentive target for each 1% of attainment between 50% and 75%;
1% of incentive target for each 1% of attainment between 75% and 100%; and
Once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation.
For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay 0% up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.
The applicable full salary ranges for this position, by specific state, are listed below:
New York City Metro Area:
$187,300.00 - $272,700.00
Non-Metro New York state & Washington state:
$166,800.00 - $242,800.00
* For quota-based sales roles on Cisco's sales plan, the ranges provided in this posting include base pay and sales target incentive compensation combined.
** Employees in Illinois, whether exempt or non-exempt, will participate in a unique time off program to meet local requirements.
$187.3k-272.7k yearly Auto-Apply 9d ago
Quality Assurance Manager
Henkel 4.7
Quality manager job in Bay Point, CA
Adhesive TechnologiesQualityUnited States, Bay Point, CA, CAFull TimeRegular **_About_** **_this_** **_Position_** At Henkel, you'll be part of an organization that's shaping the future through innovation, sustainability and collaboration. With our trusted brands like Persil , 'all , Loctite , Snuggle , and Schwarzkopf and our cutting-edge technologies, you'll have countless opportunities to explore new paths and grow.
This position is with our Adhesive Technologies business unit - where we empower our people to transform industries and provide our customers with a competitive advantage through adhesives, sealants and functional coatings.
**Dare to learn new skills, advance in your career and make an impact at Henkel.**
**What youยดll do**
+ Develop and implement quality plans and processes to support the overall quality strategy of Henkel customers.
+ Ensure that customer requirements are met and customer satisfaction is continuously improved.
+ Drive initiatives to reduce customer complaints and manage response plans when quality components do not meet expectations.
+ Provide training to ensure adherence to customer quality processes and tools throughout the organization.
+ Oversee customer quality processes including scorecards, specifications, complaints, portals, questionnaires and contracts.
+ Coordinate responses to customer requests with key internal contacts as needed.
+ Supports certification audit preparation, internal and external quality audits, and executes customer specific requirements.
+ Serve as the regional Quality Key Account Manager (KAM) for assigned customers and support the Global Quality Key
+ Account Manager. Drive the proper utilization of the global customer requirements and customer satisfaction database.
**What makes you a good fit**
+ engineering
+ incident investigation
+ root-cause-analysis
+ quality management systems
+ quality international standard
+ HACCP
+ quality core tools
+ continuous improvement
+ six sigma, DMAIC
+ 8D FMEA
**Some benefits of joining Henkel**
+ Health Insurance: affordable plans for medical, dental, vision and wellbeing starting on day 1
+ Work-Life Balance: Paid time off including sick, vacation, holiday and volunteer time, flexible & hybrid work policies (depending on role), and vacation buy / sell program
+ Financial: 401k matching, employee share plan with voluntary investment and Henkel matching shares, annual performance bonus, service awards and student loan reimbursement
+ Family Support: 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships
+ Career Growth: diverse national and international growth opportunities, access to thousands of skills development courses, and tuition reimbursement
The salary for this role is $125000.00 - $190000.00. This is the range that we in good faith anticipate relying on when setting wages for this position. We may ultimately pay more or less than the posted range and this range. This salary range may also be modified in the future.
Henkel does not accept unsolicited resumes from search firms or employment agencies. Unsolicited referrals and resumes are considered Henkel property and therefore, Henkel will not pay a fee for any placement resulting from the receipt of an unsolicited referral.
Henkel is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information, and other legally protected categories.
**JOB ID:** 25087092
**Job Locations:** United States, CA, Bay Point, CA
**Contact information for application-related questions:** *****************************
Please do not use this email address for sending your application or CV. To apply, please click on the "Apply for this role" button below. Applications sent via e-mail will not be accepted.
**Application Deadline:** As long as the vacancy is listed on our Career Site, we are happy to receive your application
**Job-Center:** If you have an application already, you can create or log in to your accounthere (******************************************************************************************************************************************************** to check the status of your application. In case of new account creation, please use your email address that you applied with.
$125k-190k yearly Easy Apply 60d+ ago
Quality Manager - Semiconductors
Ayar Labs
Quality manager job in San Jose, CA
Quality Manager, Semiconductors Location: on-site in San Jose Ayar Labs is seeking a highly experienced and results-oriented Quality Manager to lead our Quality Assurance team and champion the development of our ISO-based Quality Management System (QMS). This pivotal role requires deep expertise in the semiconductor industry and a proven track record of successfully managing complex quality systems, especially in collaboration with leading foundries.
Key Responsibilities
This role encompasses overseeing all facets of quality management, ensuring our cutting-edge photonics-based products consistently meet the highest quality and reliability standards required by our customers and the industry. Foundry & Supplier Quality Management (Critical Focus)
Lead the development and robust management of the Supplier Quality Management (SQM) program, with a primary focus on quality excellence when engaging with major semiconductor foundries, such as TSMC, GlobalFoundries (GF), and other key partners.
Develop strong working relationships with foundry quality teams and drive alignment on process control, auditing, and quality improvement initiatives.
Conduct thorough supplier and foundry audits to ensure compliance and monitor performance against rigorous quality standards.
Collaborate closely with suppliers to proactively address quality issues and drive root cause analysis (RCA) and effective corrective actions (CA) to prevent recurrence.
Quality Management System (QMS) & Compliance
Spearhead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in full compliance with ISO-9001 standards and industry best practices.
Plan and execute internal audits to verify QMS compliance and readiness for customer and external audits.
Manage external audits, including those conducted by major customers, to ensure a smooth and successful verification of compliance.
Customer Quality & Continuous Improvement
Serve as the primary point of contact for sophisticated customer quality concerns and complaints from top-tier technology clients.
Lead rapid and rigorous Root Cause Analysis (RCA), leveraging methodologies like 8D and 5Y's, and implement effective corrective and preventive actions to ensure customer satisfaction and prevent recurrence.
Identify opportunities for process enhancements and champion initiatives utilizing methodologies such as Six Sigma and Lean to boost product quality and operational efficiency across the organization.
Leadership & Reporting
Guide, mentor, and develop the Quality Assurance team, fostering a culture of continuous improvement, accountability, and quality-first mindset.
Generate and present regular quality reports to senior management, providing clear insights into key performance indicators (KPIs), trends, and improvement roadmaps.
Basic Qualifications
Bachelor's degree in Engineering (Electrical, Mechanical, Industrial), Quality Management, or a related technical field.
Minimum of 7 years of progressive experience in quality management, with a significant emphasis on the semiconductor manufacturing industry.
Extensive, hands-on experience working directly with major semiconductor foundries (e.g., TSMC, GlobalFoundries, etc.) on process control, quality assurance, and audit management.
Deep knowledge of ISO 9001 implementation, maintenance, and auditing.
Expert-level proficiency in problem-solving techniques, including leading 8D, 5Y's, and other robust quality tools and measures.
Proven track record of successfully leading and executing quality improvement initiatives in a high-volume manufacturing environment.
A strong background or experience working with integrated photonics, silicon photonics, or optical components is a significant advantage (bonus qualification).
Exceptional leadership, team management, and cross-functional collaboration skills.
Excellent analytical, documentation, and technical reporting abilities.
This role offers an exciting opportunity to define and drive the quality strategy for a company at the forefront of the silicon photonics revolution. Salary Range: $150,000 - $192,000 NOTE TO RECRUITERS:
Principals only. We are not accepting resumes from recruiters for this position. Remuneration for recruiting activities is only applicable subject to a signed and executed agreement between the parties. Please don't send candidates to Ayar Labs, and do not contact our managers.
About Ayar Labs:
At Ayar Labs we're about to revolutionize computing by moving data with light. We're unleashing processing power for artificial intelligence, high performance computing, cloud and telecommunications by removing the bottlenecks created by today's electrical I/O -- making it possible to continue scaling computing system performance. Ayar Labs is the first to deliver an optical I/O solution that combines in-package optical I/O chiplets and multi-wavelength remote light sources to replace traditional electrical I/O. This silicon photonics-based I/O solution enables chips to communicate with each other from millimeters to kilometers, to deliver orders of magnitude improvements in latency, bandwidth density, and power consumption.
With our strong collaborations with industry leaders and government, our deep ties to MIT and UC Berkeley, and our commitment to hiring the best engineers in photonics and electronics, joining our team gives you the opportunity to collaborate with renowned experts on challenging, paradigm-shifting work.
We are passionate about delivering in-package optical I/O at scale, leveraging the strength of our patent portfolio and our team of leading interdisciplinary experts. We believe that deep cross-collaboration between teams facilitated by honest, open debate is the best way to drive innovation and achieve big wins. Join our team and experience the possibilities.
Resources:
Executives from Intel and GLOBALFOUNDRIES share their thoughts on Ayar Labs and the promise of in-package optical I/O (video)
Ayar Labs in the News and Recent announcements
LinkedIn and Twitter
Ayar Labs is an Affirmative Action/Equal Opportunity Employer and is strongly committed to all policies which will afford equal opportunity employment to all qualified persons without regard to age, sex, national origin, race, color, ethnicity, creed, religion, gender identity, sexual orientation, disability, veteran status, or any other characteristic protected by law. It is the policy of Ayar Labs to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. Veterans are more than welcome and encouraged to apply.
$150k-192k yearly 60d+ ago
Manager, Quality
Delphon Industries LLC
Quality manager job in Hayward, CA
Job DescriptionDescription:
The Manager, Quality, is responsible for overseeing and maintaining the Quality Management System (QMS) in compliance with ISO standards, FDA guidelines (as applicable), and customer requirements for Delphon's Hayward facility. The Hayward facility supports the product realization activities of Gel-Pak, and TouchMark divisions. Gel-Pak develops and manufactures a family of elastomer-based carriers and films designed to provide maximum protection during the shipping, handling and processing of delicate devices. TouchMark provides high quality precision pad printing and manufacturing services to the medical device, diagnostics, and electronics industries. The Manager, Quality is responsible for developing and enforcing quality procedures, leading internal audits, managing the Quality team, and collaborating cross-functionally to drive continuous improvement. The Manager, Quality serves as the ISO Management Representative for the Hayward facility and ensures compliance with all applicable state, federal, and local regulations.
ESSENTIAL DUTIES AND RESPONSIBILITES
Responsibilities include but are not limited to:
โข Ensure quality through oversight and guidance throughout design, development, and production.
โข Conduct investigations into product and process non-conformances; oversee corrective and preventive actions (CAPA); maintain relevant documentation.
โข Handle customer complaints inclusive of RMA (Return Merchandise Authorization), and SCAR (Supplier Corrective Action Requests) s; ensure timely resolution and effective communication with relevant stakeholders (internal and external).
โข Maintain the ISO 9001 Quality Management System (QMS); lead internal audits and prepare for customer and regulatory audits.
โข Ensure compliance with document control procedures; review and approve quality records and manufacturing deviations.
โข Lead Material Review Board (MRB) and support failure analysis, FMEA (Failure Mode Effects Analysis), and risk assessments.
โข Develop and maintain control plans, inspection standards, and calibration systems.
โข Manage Hayward production employee training records, certifications, and training effectiveness reviews.
โข Track and report KPIs, efficiency, and quality metrics for the organization and use DMAIC process to drive real improvements, including YoY reduction of quality issues.
โข Collaborate with Engineering, Production, and Customer Service departments to drive continuous improvement.
โข Ensure a safe and healthy work environment in accordance with Cal/OSHA and company safety standards.
โข Support change control, Coordinate Measuring Machine programming, process capability studies, and Gage Repeatability and Reproducibility (GR&R).
โข Participate in ISO management reviews, customer surveys, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and audits.
โข Maintain EQMS (Enterprise Quality Management System), ERP (Enterprise Resource Planning) systems, and Quality department dashboards.
โข Review gross margin impacts related to quality and efficiency issues.
โข Oversee the daily activities of the department across both the day (6:30 am to 2:00 pm) and swing shifts (2:30 pm to 11:00 pm), including scheduling, training, and performance management. Be on-site from time to time during swing shifts to provide oversight and support. In the absence of the Quality Supervisor, be present on-site as needed to ensure support for both day and shifts.
โข Oversee recruitment, training, and performance evaluation within the Quality department, contributing to the onboarding and professional development of the Quality team.
ACCOUNTABILTIES
Supervisory
Supervising, scheduling, assigning, monitoring, and evaluating the work of assigned staff are responsibilities for supervisory positions as well as promoting a respectful, inclusive, and harassment-free workplace.
โข Direct Reports: Supervisor, Quality, Quality Technicians.
โข Indirect Reports: None
Fiscal
โข Department budget development and expense management.
โข Departmental purchase order request review and submissions
Requirements:
ESSENTIAL EDUCATION AND TRAINING REQUIREMENTS
โข Bachelor's degree in engineering, Quality, or related technical field.
โข 5+ years' experience in a quality or regulated manufacturing environment.
โข 3+ experience working in a highly regulated industry. Medical device or semiconductor manufacturing preferred.
โข Strong working knowledge of ISO 9001; working knowledge of ISO 13485. Familiarity with FDA Quality System Regulations is a plus.
โข Strong working knowledge of MS Suite (Outlook, Excel, Word, PowerPoint specifically)
โข Proficiency in ERP systems, EQMS, and basic working knowledge of CAD tools.
โข Able to read, speak and understand English text, instructions, and diagrams.
โข Strong leadership, problem-solving, and organizational abilities.
Work Environment and Physical Demands
โข Operates in both an office and manufacturing environment.
โข Able to sit, stand, and walk within a confined manufacturing space.
โข Able bend, twist, turn, reach, and lift to 50 pounds.
โข Frequent use of computers, standard office equipment, and manufacturing-oriented measurement tools.
โข Travel required for audits and customer visits will be infrequent, typically 10-15%.
โข Maintain 1) reliable and safe transportation to Delphon facilities, customers and for other business travel, 2) valid State-issued driver's license, 3) proper vehicle registration, and 4) State-required minimum automobile insurance coverage requirement.
$98k-159k yearly est. 22d ago
Quality Manager
Rani Therapeutics 4.5
Quality manager job in Fremont, CA
GENERAL INFORMATION Quality Manager - Medical Device / Combination Product Department: Quality Reports to: VP of Quality Purpose of the job Lead and manage quality assurance processes in the development and manufacturing of combination products (drug-device), ensuring operational effectiveness, regulatory compliance, and robust application of design control and engineering fundamentals. The Quality Manager serves as the key quality lead in cross-functional teams, collaborating with engineering, production, clinical and regulatory partners. The ideal candidate will have working knowledge in the design control requirements for medical device and hands-on experience in product life cycle, from feasibility prototype through product commercialization. The candidate will provide quality and compliance input to the project team for project decisions and deliverables (e.g., Product Specifications, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation). The candidate shall have the capacity to prioritize project activities and work within a multidisciplinary team.
Major Duties and Responsibilities
Team Leadership
Mentor, develop, and supervise a multidisciplinary quality team, including quality engineers, specialists, and inspectors.
Set clear objectives and performance expectations, provide regular feedback, and drive a culture of accountability, empowerment, and continuous learning.
Oversee calibration and preventive maintenance program.
Lead by example, inspiring commitment to quality across the organization.
Cross-functional Collaboration
Serve as the quality lead for multidisciplinary teams (R&D, regulatory, manufacturing, engineering, supply chain), ensuring quality requirements are integrated at every product stage.
Facilitate effective communication and alignment, resolve conflicts proactively, and drive collaborative problem-solving.
Support and influence cross-functional projects, including but not limited to design control design and product transfer.
Quality Assurance & Compliance
Provide quality assurance oversight and ensure compliance in the support of combination device development life cycles.
Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.
Oversee compliance for combination device development life cycles according to FDA regulations (21 CFR part 4 & 820), ISO 13485, EU MDR, and other regulatory body regulations and guidelines.
Provide QA oversight for development projects and changes to existing products.
Support internal and external audits, CAPA and NCMRs.
Design Control & Engineering Support
Apply knowledge of design control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, design verification & validation, process characterization & validation, component qualification.
Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA regulations (21 CFR part 4 & 820), ISO 13485, EU MDR requirements, and ISO 14971.
Work with R&D in the creation of requirements for new products and engineering specifications.
Evaluate product changes for qualification and validation requirements and assist in change implementations.
Risk, Validation, and Process Management
Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies.
Lead risk management activities and participate in cross-functional teams to develop and maintain product risk management files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.).
Lead test method validation activities and Gage R&R studies for Combination Product.
Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports.
Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
Other duties/ activities may be necessary to support departmental or company goals.
Education and/or Job Experience
A minimum of 8 years quality assurance/engineering in a regulated industry (medical device,) is required.
BS degree in Mechanical Engineering or related field is required.
A minimum of 3 years of experience supervising employees
Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, EU MDR, ISO 13485.
Experience with Risk Management process per ISO 14971 (Risk Management Plan/Report, FMEA's).
Understanding of multiple technological areas (software, mechanical, electrical, biomedical, test automation).
Must be a self-starter and capable of working independently and within a team.
Experience performing statistical analysis (Six Sigma preferred).
CQE, CQA preferred.
Skills and Specifications
Ability to motivate and influence people.
Must possess the ability to handle multiple tasks with high attention to detail, planning, and problem-solving skills.
Good interpersonal and communication skills.
Ability to work as a part of a team.
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate. recommendations and decisions; write reports.
Ability to create and provide training.
Good statistical and numerical ability.
$102k-153k yearly est. 54d ago
Director, Parenteral Sterility Assurance
Eli Lilly and Company 4.6
Quality manager job in Concord, CA
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
Responsibilities:
* Assess differences in current sterility assurance programs across the sites and drive harmonization
* Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
* Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
* Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network.
* Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs.
* Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.
* Building, maintaining, and growing capability across the organization in the sterility assurance space
* Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability.
* Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites.
* Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.
* Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing.
* Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
* Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections
* Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
Basic Qualifications:
* BS Degree required.
* MS/PhD in a biological science preferred.
* 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred.
* 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred.
* Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)
* Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
* Strong written and oral communication skills
* Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology
* Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance
* Demonstrated experience influencing site and network leaders to advance technical agenda projects
Additional Preferences:
* Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
* Support the establishment of a sterility assurance network or hub in global TSMS
* Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
* Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space
* Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance
* Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.
* Strong capability to influence personnel and management across the organization
* Close interaction with quality to enable internal audits that identify risks
* Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.
Additional Information:
* Approximately 25% travel
Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$133,500 - $246,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$133.5k-220k yearly Auto-Apply 60d+ ago
Director, Quality Assurance and Regulatory Affairs
Noah Homes 4.1
Quality manager job in San Jose, CA
Who We Are
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About The Team
The Director of RA/QA reports to the Head of Quality and Regulatory. This position is the day to day leader of the RA/QA function and provides guidance and leadership from a Regulatory and Quality perspective to the team throughout all stages of product development. We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well); must be a self-starter, team builder, and excellent in communication.
A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs at Noah Medical
Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones.
Involved in developing, modifying and executing RA/QA related company policies, which affect immediate operation(s) and may also have company-wide effect.
Manages the RA/QA department functions through direct reports or subordinates.
Regularly interacts with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in sensitive situations.
Supports defining, training and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements.
Coordinates the planning and organization of regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service
Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions.
May serve as the designated Management Representative.
About You
Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc.
Minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
Minimum of 3 years of supervisory experience of multiple exempt level employees.
Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams.
Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.
Experienced in conducting internal and supplier audits and hosting 3rd party audits.
Must be a self-starter, team builder, and excellent in verbal and written communication.
Preferred: Knowledge of sterile/disposable medical device production processes.
Preferred: Master Degree, MBA, experienced with Software Validation,
Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.
#LI-Hybrid
Pay Transparency
The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules.
Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.
California Pay Range$201,000-$251,000 USD
Benefits & Perks (For Full Time Employees):
Competitive Salary
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, 15-20 days of PTO + sick time
Paid parental leave
In-office snacks and beverages
In-office lunch stipend
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
Please visit our Careers Page to view our latest openings.
NO AGENCIES PLEASE -
Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and
no fee will be paid.
$201k-251k yearly Auto-Apply 60d+ ago
Quality Manager
Overview Prince 4.1
Quality manager job in Concord, CA
Are you passionate about ensuring excellence and compliance in every detail? As a Quality Manager, you will play a pivotal role in planning, supervising and monitoring quality assurance activities across multiple projects within a district. Collaborate with industry experts and committed teams to ensure that every project meets the highest standards of quality.
One of our Water Treatment plant projects in the East Bay is currently in need of an experienced Quality Manager. This position will be on site at the project working with our operations team to ensure that all quality standards are met during the construction of a large scale water infrasctructure project.
Apply now and transform your career with us.
What you will be doing
Oversees quality procedures on project sites within the District, ensuring accurate documentation, procedures, and testing of required items in the contract specifications. Develops and manages quality control plans for projects in the assigned District.
Conducts and prepares internal and external audit documentation and reporting to support project site quality activities and compliance. Assists in company non-conformance reports and resolutions.
Identifies risks at the project site and discrepancies during daily site walks. Documents findings, evaluations, and inspections using Company-prescribed procedures and software.
Performs system verifications on completed systems to ensure correct installation per contract design specifications.
Documents, analyzes, and reports environmental performance to internal and external clients and regulatory bodies.
Manages impact assessments to identify, assess, and reduce the organization's environmental risks and financial costs, following the direction of the environmental team and procedures.
What we are looking for
Bachelor's degree or Engineering Technologist Diploma preferred.
A minimum of 10 years of verifiable experience as a Quality Control Manager including for a similar size and type project as USL/SOB WTP is required.
Maintain current certification of completion for Construction Quality Management for Contractors offered by the United States Army Corps of Engineers and Navy Facilities Engineering Command is required.
Demonstrated experience working on projects with a similar scope of work as this project. Mechanical, electrical, instrumentation, and control work experience shall be minimum required qualifications.
ASQ and/or ACI required in the US.
Canadian equivalent certification preferred.
Experience or training in environmental regulatory and construction industry compliance preferred.
Proven subject matter expert in testing, inspection processes and construction procedures.
Proven leadership, coaching and mentoring ability and ownership.
Strong organization and communication skills.
Willingness and ability to learn and grow in environmental monitoring, technical writing and documentation.
Why work for us
Some of the benefits you may be eligible for as an employee are:
Comprehensive compensation package and paid time off program
Industry leading 401(k)/RRSP
Medical/Extended Health Care, Dental, Vision and/or Provincial Medical
Wellness benefits & Employee Assistance Program
Tuition Reimbursement Program
We are an EEO/ADA/Veterans employer.
Salary Min USD $135,000.00/Yr. Salary Max USD $160,000.00/Yr. Vehicle Program Personal Vehicle Allowance Tier I: $750 USD/month
$135k-160k yearly Auto-Apply 12d ago
Quality Manager
Regalrexnord
Quality manager job in Fremont, CA
We are seeking a Quality Manager to join our Fremont team. The ideal candidate brings a solid background in quality management and a hands-on approach to ensuring products meet the highest standards. In this role, you'll develop and maintain quality systems, procedures, and controls, while working closely with internal teams, customers, and suppliers to quickly and effectively resolve issues. You'll play a key role in driving compliance, supporting continuous improvement, and ensuring reliable product performance through strong problem-solving and collaboration.
Key Responsibilities:
Establish a quality system continuous improvement program
Manage challenging customer quality requirements such as PPAP
Own the problem-solving process for quality and drive usage through quality team
Drive quality direction for new product development and commercialization to ensure products meet performance standards and are highly manufacturable from a quality perspective.
Establish and maintain critical-to-quality specifications, test plans, procedures, tools, and meaningful metrics to control all aspects of manufacturing.
Lead resolution of customer complaints, coordinating cross-functional efforts to identify root causes and implement timely, effective, and permanent solutions.
Oversee Returned Material Authorization (RMA) processes, providing guidance to ensure efficient and accurate handling of returned products.
Develop and execute plans for qualifying new suppliers and raw materials, and work proactively to resolve supplier quality issues quickly and permanently.
Champion a quality culture by training and mentoring team members on best practices and compliance standards.
Collaborate with top OEM customers to drive quality improvements and help the plant achieve and maintain preferred supplier ratings.
Required Skills and Qualifications:
Bachelor's degree in engineering, manufacturing or related field
Minimum of 5 years of experience in manufacturing or quality-related roles
Solid understanding of Quality Systems, Methods, and Statistical Process Control (SPC)
Understanding of ITAR, PPAP, ISO9001, ISO13485 and AS9001
Knowledge of quality principles in a Lean Manufacturing environment.
Proven ability to act as a change agent, driving process improvements through collaboration and influence.
Strong interpersonal and customer service skills, with the ability to build relationships and influence outcomes.
Demonstrated leadership skills, including setting priorities, managing by data, and driving results through structured processes.
Working knowledge of Six Sigma methodology and tools
Green Belt or Black Belt certification is a plus.
Candidates must be eligible to work in the United States without requiring company sponsorship to obtain or keep U.S. work authorization.
Expected Base Salary Range: $110,000 to $140,000
The salary range provided is intended to display the value of the company's base pay compensation for this position. Salary is dependent on a multitude of factors, including but not limited to the physical worksite location, the geographic market of that location, candidate's skill set, level of experience, education and internal peer compensation comparisons among other potential factors.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation will be made to enable individuals with disabilities to perform these functions.
While performing the duties of this job, the employee is regularly required to use hands to handle or feel objects, operate tools, and reach with hands and arms Frequent activities include standing, walking, and sitting. Occasional activities include climbing, balancing, stooping, kneeling, crouching, or crawling. This position requires the ability to lift and move materials weighing up to 25 pounds on a daily basis.
Work Environment
Noise levels are typically low to moderate. This position involves working in both office and manufacturing environments.
Benefits
Medical, Dental, Vision and Prescription Drug Coverage
Spending accounts (HSA, Health Care FSA and Dependent Care FSA)
Paid Time Off and Holidays
401k Retirement Plan with Matching Employer Contributions
Life and Accidental Death & Dismemberment (AD&D) Insurance
Paid Leaves
Tuition Assistance
About Regal Rexnord
Regal Rexnord is a publicly held global industrial manufacturer with 30,000 associates around the world who help create a better tomorrow by providing sustainable solutions that power, transmit and control motion. The Company's electric motors and air moving subsystems provide the power to create motion. A portfolio of highly engineered power transmission components and subsystems efficiently transmits motion to power industrial applications. The Company's automation offering, comprised of controls, actuators, drives, and precision motors, controls motion in applications ranging from factory automation to precision control in surgical tools.
The Company's end markets benefit from meaningful secular demand tailwinds, and include factory automation, food & beverage, aerospace, medical, data center, warehouse, alternative energy, residential and commercial buildings, general industrial, construction, metals and mining, and agriculture.
Regal Rexnord is comprised of three operating segments: Industrial Powertrain Solutions, Power Efficiency Solutions, and Automation & Motion Control. Regal Rexnord has offices and manufacturing, sales and service facilities worldwide. For more information, including a copy of our Sustainability Report, visit RegalRexnord.com.
Equal Employment Opportunity Statement
Regal Rexnord is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex/gender, sexual orientation, gender identity, pregnancy, age, ancestry, national origin, genetic information, marital status, citizenship status (unless required by the applicable law or government contract), disability or protected veteran status or any other status or characteristic protected by law. Regal Rexnord is committed to a diverse and inclusive workforce. We are committed to building a team that represents diverse and inclusive backgrounds, perspectives, and skills. If you'd like to view a copy of the company's affirmative action plan for protected veterans/individuals with disabilities or policy statement, please email ***************************. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ***************************.
Equal Employment Opportunity Posters
Notification to Agencies: Please note that Regal Rexnord Corporation and its affiliates and subsidiaries ("Regal Rexnord") do not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement or similar contract and approval from HR to submit resumes for a specific requisition, Regal Rexnord will not consider or approve payment to any third-parties for hires made.
$110k-140k yearly Auto-Apply 41d ago
Principal Quality Manager
Celerity Consulting Group
Quality manager job in Walnut Creek, CA
Principal Quality Manager - Utility Data & Systems Employment Type: Full-Time, Exempt Department: Utility Services Reports To: Program or Quality Leadership Salary Range: $115,000 - $140,000
The Principal Quality Manager leads quality assurance, corrective action programs, and compliance support for electric utility asset data and GIS systems. This role ensures that data, processes, and deliverables meet defined quality standards and regulatory expectations in a highly regulated utility environment.
The role partners with program leadership, GIS teams, data managers, and field validation resources to proactively identify quality risks and drive corrective and preventive actions.
Key Responsibilities
Quality Assurance & Quality Control
Lead QA/QC reviews of electric utility asset data and GIS records
Define quality standards, acceptance criteria, and review procedures
Ensure consistent application of QA/QC processes across programs
Corrective Action & Continuous Improvement
Manage corrective action programs, including issue tracking, root cause analysis, and closure verification
Monitor quality metrics and trends to identify systemic issues
Support Plan-Do-Check-Act (PDCA) cycles and continuous improvement efforts
Compliance & Audit Support
Support internal and external audits related to data quality, governance, and compliance
Develop and maintain quality documentation, reports, and dashboards
Ensure alignment with client, regulatory, and internal quality requirements
Collaboration & Risk Management
Partner with program, data, and process teams to identify and mitigate quality risks
Provide guidance to delivery teams on quality expectations and best practices
Support escalation and resolution of high-risk quality issues
Required Qualifications
Education
Bachelor's degree required (Engineering, Quality, or related field preferred)
Experience
7+ years of experience in quality management, QA/QC, or compliance roles
Experience supporting data, systems, or asset programs
Skills & Competencies
Strong attention to detail and risk awareness
Experience managing corrective action programs and quality metrics
Strong documentation and reporting skills
Ability to work across technical and non-technical teams
Preferred Experience
Experience supporting utility data, GIS, or infrastructure programs
Familiarity with regulated or compliance-driven environments
The salary range for this position is provided in good faith and is subject to variation based on geographic location, candidate experience, and market conditions. Final compensation will be determined after a comprehensive evaluation of the candidate's qualifications and alignment with the role.
In accordance with applicable pay transparency laws-including but not limited to those in California, Colorado, New York, Washington, and other jurisdictions-we disclose salary ranges to promote equity and transparency. Where required by law, compensation and benefits information will be included in job postings or made available upon request.
This job description outlines the primary responsibilities and standards of the position but is not exhaustive. Employees may be asked to perform additional duties that are reasonably related to their role and consistent with company policies and applicable labor laws.
Employee welfare and development is important to us, and we sponsor many activities outside of work to promote team building as well as sponsor formal training and certification. We are proud to offer a comprehensive health and welfare benefit package that includes:
HEALTH & WELL-BEING
Medical Insurance
Dental Insurance
Vision Insurance
PEACE OF MIND
Disability Insurance (STD/LTD)
Flexible Spending Account
Health Savings Account
Basic Life/AD&D
401(k) plan
WORK/LIFE BALANCE
Paid Time Off
Company Holidays
Leave of Absence
Flexible Work Schedules
ADDITIONAL PERKS
Employee Referral Program
Professional Development
Charitable Contribution Match
Based in Walnut Creek, CA with offices nationwide, Celerity energy engineers perform a critical, leadership role as strategic liaisons between data, assets and the teams that make projects happen in the field.
See full details and meet our leadership team on our website: ********************************
Celerity is an Equal Employment Opportunity (EEO) employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veterans' status or other status protected by applicable law.
Pursuant to the Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
This position is open to individuals who are currently authorized to work in the United States on a full-time basis. Unfortunately, we are unable to sponsor or assume sponsorship of employment visas at this time.
$115k-140k yearly Auto-Apply 18d ago
Quality Manager
Altium Packaging LLC
Quality manager job in Tracy, CA
75 W Valpico Road, Tracy, California 95376 Work Shift: Salary Exempt (United States of America) Leads administration of quality, process, and business improvement efforts. Interacts with customers and suppliers on quality and performance issues. Willhave direct reports to implement some aspects of the policies and procedures within the quality function.
JOB SUMMARY:
Leads administration of quality, process, and business improvement efforts. Interacts with customers and suppliers on quality and performance issues. Will have direct reports to implement some aspects of the policies and procedures within the quality function.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Champion a safety culture, ensure a safe work environment and cultivate safe behavior.
Sets goals and objectives for team members, assists with their accomplishment.
Audit facility for compliance with GMP standards and maintain plant in compliance with corporate quality requirements.
Ensures that testing standards, procedures, and equipment provide reliable results and prevent shipment of defective products.
Lead problem-solving and process improvement with the plant and the customer to achieve resolution and elimination of product issues.
Train, Mentor and develop technicians and peers to be skilled experts in the application of Quality tools (SPC, DOE, Centerlining Process, Control Plans, Problem Solving, etc.).
Establishes plant audit and standards, procedures, and equipment to provide accurate test results. Provide methods of measuring product.
Visit customer sites to gain knowledge of customer process and assist with quality problem-solving issues.
Comply with regulatory agencies, AIB, IMS and company's good manufacturing standards
Utilizes approved statistical standards such as CPK, Tz and others.
Maintain testing laboratory equipment accurately calibrated and in proper repair.
Provide for successful new product launches, by ensuring clear specification development, process capability definition, and attainment of customer satisfaction on initial shipments.
Analyze processes and systems to create continuous process improvements through measurement, analysis and improvement plans.
Interview employment candidates and authorizes personnel hires. Authorizes employment actions of plant personnel.
Develop and improve the skill and knowledge of immediate staff and hourly personnel; will maintain training and development documentation.
* Reasonable mandatory overtime may be required due to business needs.
* Must have SQF experience.
* 6 to 10 years Quality management experience with progressive levels of responsibility
Targeted Pay Range:
$78,200.00 - $96,600.00
Altium Packaging, Our Culture Differentiates Us!
We incorporate our Guiding Principles into all aspects and at all levels of the organization and use them as a framework for decision-making. We believe our Guiding Principles foster a culture of excellence that benefits both employees and customers.
Our Guiding Principles
* Act with Integrity & in Compliance
* Drive Value Creation
* Be Disciplined Entrepreneurs
* Focus on the Customer
* Act with Humility
* Treat others with Dignity and Respect
* Seeking Fulfillment in your Work
We Believe in Rewarding our Most Important Resource - Our People!
We show our commitment to Total Rewards by providing a competitive, comprehensive benefits package. In addition to medical, dental and vision plans, company holidays and vacation days, tuition reimbursement, learning and training opportunities, bonus potential, and a 401(k) plan with company contributions, Altium Packaging locations offer rewards and recognition programs and opportunities to make a difference in the community.
EEO Statement
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.
Take your career to the next level at Altium Packaging!
$78.2k-96.6k yearly Auto-Apply 22d ago
Supplier Quality Manager
BD (Becton, Dickinson and Company
Quality manager job in Milpitas, CA
The Manager of Supplier Quality reports to the Plant Quality Head, BD Biosciences (BDB) Business Milpitas Unit. This position is responsible for all aspects of the BDB supplier quality management including quality management of the OEM instruments and consumable materials. This role will oversee supplier management activities at all BDB Milpitas and other sites as needed and will be responsible for development and implementation of the BDB-Wide supplier management program. The role will have direct reports in Milpitas, CA and will establish indirect oversight over other BDB facilities as needed. An individual in this position will have the responsibility of development and execution of the supplier management quality strategy and plan, development and execution of the supplier evaluation, assessment and audit schedules, ensuring training and availability of supplier auditors for BDB. The supplier management organization will also be responsible for complaint investigation and trending activities for OEM instruments and consumables. This position is responsible for planning and implementing a Supplier Quality strategy for BDB that is aligned with key strategic business strategies. The position implements policies to ensure compliance with applicable US federal regulations, California state requirements, and global regulations.
**Job Description**
We are **the makers of possible**
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a **maker of possible** with us.
**Key Responsibilities for this Role:**
+ Develop and execute quality strategy for supplier management activities and establish goals and metrics for Category suppliers.
+ Manage and ensure timely and effective customer complaint closure for OEM instruments and consumables.
+ Establish strong links with OEM and key supplier organizations and build a culture of continuous improvement with key BDB suppliers.
+ Lead, develop, engage and mentor quality organization responsible for supplier management under direct supervision and across BDB manufacturing plants.
+ Continuously improve quality processes and quality system with the goal of improving regulatory compliance, product quality, cost and customer satisfaction.
+ Establish quality agreements with key BDB suppliers.
+ Proactively manage quality of the OEM, component and subassembly suppliers.
+ Lead implementation and utilization of quality tools such as six sigma, risk management, SPC, root cause analysis, and DOE for supplier management organization.
+ Maintain quality management responsibilities in appropriate databases and serve as the BDB representative on the corporate supplier management network.
**Key Qualifications and Attributes:**
+ Supplier Quality Manager should possess strong knowledge of WW medical device regulations and quality sciences with specific focus on Class II and CE-IVD(R) manufacturing and purchasing controls. An In-Vitro-Diagnostic Knowledge is required.
+ An individual in this role must have excellent leadership, communication, organization and project management skills.
+ Strong knowledge of supplier management practices is required.
+ The ability to make timely critical decisions regarding product quality and/or quality system compliance.
+ The ability to effectively lead teams and influence.
+ An expert understanding of quality engineering sciences and their application to supplier controls.
+ A thorough understanding of 21 CFR ยง820, ISO 13485, ISO 9001 and ISO 14971.
+ Experience as an interface in regulatory compliance audits such as the FDA, ISO, PAL, Anvisa, MDSAP and others.
+ The ability to prepare, and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies, etc.
+ The ability to assess and articulate risk when evaluating a situation.
+ The ability to perform thorough investigations, identify root cause(s) of an issue, and propose appropriate corrective action(s).
+ The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams.
**Position Requirements**
**EDUCATION**
+ Bachelor of Science in Engineering, Science, or other technical discipline is required.
**LICENSES OR CERTIFICATIONS**
+ ASQ certification desired.
**EXPERIENCE**
+ A minimum of 5 years of quality assurance or relevant experience. A minimum of 2 years of quality leadership or relevant experience. Experience should be in the Medical Device or Bioscience industry.
+ Significant experience in FDA regulations and ISO requirements. Ideally previously involved with remediation activities within manufacturing, design, and transactional organizations.
**SPECIAL SKILLS**
+ Good communication and presentation skills, Project Management, Trackwise systems, SAP.
+ Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
**KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES**
+ Knowledge of US and International regulations and standards that apply to the _in vitro_ diagnostic and medical device industry, including FDA Quality Systems Regulations, MDSAP, ISO 13485 & 9001, ISO 14971, EU MDD/IVD, EU MDR/IVDR, SOR/98-282, TG(MD) R, RDC 16, Ordinance #169.
+ In-depth understanding of the application of QS to the medical device industry.
**COMPLEXITY OF DUTIES**
+ Must be able to balance a complex agenda, ability to multitask.
+ Must be well organized and methodical. Partners with R&D, Operations, NPD Quality Engineering, Quality Leaders of all manufacturing sites.
+ Works across BDX to share improvements and learn from others on areas for potential improvements.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
**Why Join Us?**
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
.
**Primary Work Location**
USA CA - Milpitas 155
**Additional Locations**
**Work Shift**
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (********************************************* .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
**Salary Range Information**
$132,400.00 - $218,400.00 USD Annual
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
$132.4k-218.4k yearly 4d ago
Supplier Quality Manager
BD Systems 4.5
Quality manager job in Milpitas, CA
SummaryThe Manager of Supplier Quality reports to the Plant Quality Head, BD Biosciences (BDB) Business Milpitas Unit. This position is responsible for all aspects of the BDB supplier quality management including quality management of the OEM instruments and consumable materials. This role will oversee supplier management activities at all BDB Milpitas and other sites as needed and will be responsible for development and implementation of the BDB-Wide supplier management program. The role will have direct reports in Milpitas, CA and will establish indirect oversight over other BDB facilities as needed. An individual in this position will have the responsibility of development and execution of the supplier management quality strategy and plan, development and execution of the supplier evaluation, assessment and audit schedules, ensuring training and availability of supplier auditors for BDB. The supplier management organization will also be responsible for complaint investigation and trending activities for OEM instruments and consumables. This position is responsible for planning and implementing a Supplier Quality strategy for BDB that is aligned with key strategic business strategies. The position implements policies to ensure compliance with applicable US federal regulations, California state requirements, and global regulations.Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of healthโข is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Key Responsibilities for this Role:
Develop and execute quality strategy for supplier management activities and establish goals and metrics for Category suppliers.
Manage and ensure timely and effective customer complaint closure for OEM instruments and consumables.
Establish strong links with OEM and key supplier organizations and build a culture of continuous improvement with key BDB suppliers.
Lead, develop, engage and mentor quality organization responsible for supplier management under direct supervision and across BDB manufacturing plants.
Continuously improve quality processes and quality system with the goal of improving regulatory compliance, product quality, cost and customer satisfaction.
Establish quality agreements with key BDB suppliers.
Proactively manage quality of the OEM, component and subassembly suppliers.
Lead implementation and utilization of quality tools such as six sigma, risk management, SPC, root cause analysis, and DOE for supplier management organization.
Maintain quality management responsibilities in appropriate databases and serve as the BDB representative on the corporate supplier management network.
Key Qualifications and Attributes:
Supplier Quality Manager should possess strong knowledge of WW medical device regulations and quality sciences with specific focus on Class II and CE-IVD(R) manufacturing and purchasing controls. An In-Vitro-Diagnostic Knowledge is required.
An individual in this role must have excellent leadership, communication, organization and project management skills.
Strong knowledge of supplier management practices is required.
The ability to make timely critical decisions regarding product quality and/or quality system compliance.
The ability to effectively lead teams and influence.
An expert understanding of quality engineering sciences and their application to supplier controls.
A thorough understanding of 21 CFR ยง820, ISO 13485, ISO 9001 and ISO 14971.
Experience as an interface in regulatory compliance audits such as the FDA, ISO, PAL, Anvisa, MDSAP and others.
The ability to prepare, and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies, etc.
The ability to assess and articulate risk when evaluating a situation.
The ability to perform thorough investigations, identify root cause(s) of an issue, and propose appropriate corrective action(s).
The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams.
Position Requirements
EDUCATION
Bachelor of Science in Engineering, Science, or other technical discipline is required.
LICENSES OR CERTIFICATIONS
ASQ certification desired.
EXPERIENCE
A minimum of 5 years of quality assurance or relevant experience. A minimum of 2 years of quality leadership or relevant experience. Experience should be in the Medical Device or Bioscience industry.
Significant experience in FDA regulations and ISO requirements. Ideally previously involved with remediation activities within manufacturing, design, and transactional organizations.
SPECIAL SKILLS
Good communication and presentation skills, Project Management, Trackwise systems, SAP.
Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES
Knowledge of US and International regulations and standards that apply to the
in vitro
diagnostic and medical device industry, including FDA Quality Systems Regulations, MDSAP, ISO 13485 & 9001, ISO 14971, EU MDD/IVD, EU MDR/IVDR, SOR/98-282, TG(MD) R, RDC 16, Ordinance #169.
In-depth understanding of the application of QS to the medical device industry.
COMPLEXITY OF DUTIES
Must be able to balance a complex agenda, ability to multitask.
Must be well organized and methodical. Partners with R&D, Operations, NPD Quality Engineering, Quality Leaders of all manufacturing sites.
Works across BDX to share improvements and learn from others on areas for potential improvements.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
.
Primary Work LocationUSA CA - Milpitas 155Additional LocationsWork Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$132,400.00 - $218,400.00 USD Annual
$132.4k-218.4k yearly Auto-Apply 6d ago
Assurance Director
BDO USA 4.8
Quality manager job in San Jose, CA
The Assurance Director title is reserved for professionals who achieve recognition in a technical area of assurance and risk management. The person is qualified to perform certain limited yet critical additional technical functions as an Engagement Director or as a Concurring Reviewer. These additional responsibilities are conferred only as outlined above. This senior role recognizes the person as an expert of great long-term value to the firm.
Job Duties:
Business Acumen:
Able to apply knowledge of business functions, processes and strategies to provide services, solutions and advice that considers and improves the organization as a whole as evidenced by:
Ability to understand core business operations/structure of various businesses
Demonstrates advanced knowledge of business issues, trends and industry economics
Identifies and discusses key financial and non-financial performance measures
Demonstrates ease with client communications
Technical Roles a Director may perform:
When functioning as Engagement Director:
May also be, but not required to be, a Client Service Engagement Director. In this capacity, may sign audit review and compilation reports related to these engagements, as well as engagement letters and other correspondence
Written pre-approval by the Client Service Assurance Partner and the Practice Region RTD and RBLL and the Practice Office OBLL for the specific assignment before a Director may perform duties of Engagement Director of that specific assignment
The Director must demonstrate the requisite industry experience necessary for the specified engagement
The engagement must be not designated as requiring an IQCR Review in accordance with the BDO Assurance Manual and may not be associated with or expected to be associated in the foreseeable future, which is generally a two-year horizon, with a public company.
The final review of only the financial statements and MRC must be performed by an Assurance Partner. When functioning as Concurring Reviewer where the engagement is sensitive but non-public:
Written pre-approval must be obtained from the Practice Region RTD and RBLL and the Practice Office OBLL.
The Director must demonstrate the requisite industry experience necessary to serve as a concurring reviewer for the specified engagement
The engagement may not be associated with or expected to be associated in the foreseeable future, which is generally a two-year horizon, with a public company.
When serving as a concurring reviewer, the Assurance Director should not have worked on the engagement in another capacity for the prior two-year period, and is prohibited from performing work on the engagement in other capacities
GAAP:
Has an advanced knowledge of governing principles, applying those principles to client transactions, and documenting and communicating an understanding of these principles as evidenced by:
Advanced technical knowledge in one or more areas of GAAP
Control Environment:
Has a general understanding of the collective effect of various factors on establishing, enhancing, or mitigating the effectiveness of specific policies and procedures as evidenced by:
Ability to identify critical and control points
Ability to document and validate internal control system
Ability to assess effectiveness of internal control system
Ability to make constructive suggestions to improve client internal controls and accounting procedures
GAAS:
Has an advanced knowledge of professional standards, application of the principles contained in professional standards as evidenced by:
An ability/experience teaching others GAAS procedures and providing guidance to others and affirms conclusions made by others
Other duties as required
Supervisory Responsibilities:
Review work prepared by associates, senior associates, and managers, and provide review comments as appropriate
Act as a Career Advisor to associates, senior associates, and managers as assigned
Provide verbal and written performance reviews to associates, senior associates, and managers
Qualifications, Knowledge, Skills and Abilities:
Education:
Bachelor's degree, required; major in Accounting, Finance, Economics or Statistics, preferred
Master's degree in Accountancy, preferred
Experience:
Eight (8) or more years of prior relevant audit experience and/or public accounting, private industry accounting or consulting/professional services experience, required
Prior significant supervisory experience, required
Industry expertise in one or more assurance specialty, preferred
License/Certifications:
Active licensed US CPA, recognized active International Equivalent or unique qualification as defined by BDO's Assurance Licensing Policy, required
If active international equivalent or unique qualifications, required to obtain an active US CPA license within approved timeframe as defined by firm licensing requirement guidelines
Software:
Proficient with the Microsoft Office Suite, preferred
Experience with assurance applications and research tools, preferred
Language:
N/A
Other Knowledge, Skills & Abilities:
Ability to supervise managers, seniors and staff, as the situation dictates, motivate team
Possess strong GAAP and GAAS technical skills and knowledge with possible industry expertise in a specialized and technical field of assurance
Advanced knowledge of SEC reporting rules, if required by specialization
Possess people development and delegation skills, including training/instruction
Possess executive presence - need to be able to be primary contact for the client, prepare and present presentations to clients and potential clients
Possess excellent risk management decision-making skills
Able to function as Engagement Director on certain engagements as set forth by specific policy
Get involved with other areas of practice
Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography.
California Range: $180,000 - $265,000
Colorado Range: $140,000 - $200,000
Illinois Range: $180,000 - $225,000
Maryland Range: $165,000 - $250,000
Massachusetts Range: $180,000 - $210,000
Minnesota Range: $135,000 - $185,000
New Jersey Range: $210,000 - $240,000
NYC/Long Island/Westchester Range: $165,000 - $275,000
Ohio Range: $165,000 - $210,000
Washington Range: $150,000 - $220,000
Washington DC Range: $165,000 - $250,000
$210k-240k yearly Auto-Apply 4d ago
Quality Control Manager- Ready Mix
Sparrow Company
Quality manager job in Livermore, CA
Job
DescriptionJob
DescriptionQuality
Control
Manager-
Ready
Mix
-
Livermore,
CA
$76k-116k yearly est. 14d ago
Product Quality Engineer
Skydio, Inc. 4.5
Quality manager job in Hayward, CA
Skydio is the leading US drone company and the world leader in autonomous flight, the key technology for the future of drones and aerial mobility. The Skydio team combines deep expertise in artificial intelligence, best-in-class hardware and software product development, operational excellence, and customer obsession to empower a broader, more diverse audience of drone users, from utility inspectors to first responders, soldiers in battlefield scenarios and beyond.
About the role:
We are seeking a talented multi-disciplinary quality engineer to define, implement, and continuously improve quality processes. In this role, your contributions will directly drive product quality, speed to market, productivity, and profitability.
Please Note: This position requires a regular onsite presence (4-5 days per week) at our manufacturing facility in Hayward, California.
How you'll make an impact:
* This position will span NPI and sustaining (focused initially on the vehicle itself)
* Collaborate cross-functionally with product development, manufacturing, supply chain, and software test teams to define manufacturing and product quality requirements
* Conceptualize, develop, iterate, and implement quality processes
* Identify and prioritize efforts between quality initiatives, throughput goals, and yield issues. Ability to clearly convey cost-benefit / ROI
* Drive cross-functional Material Review Board meetings to classify, prioritize, and triage issues
* Ensure defects are contained, participate in failure analysis, evaluate corrective actions and verify fixes are implemented and effective
* You will be involved with all quality facets from DFMEAs, component quality initiatives, IQC definitions, production review, field failure analysis
What makes you a good fit:
* As a representative of quality, you have excellent communication skills to promote the impact of quality while helping to meet business objectives
* Experienced in full product development lifecycle (NPI through MP)
* Experience implementing quality inspection points in manufacturing, evaluating cosmetic criteria, monitoring quality and yield metrics
* Technical whole-product engineering experience involving firmware-controlled electromechanical systems
* Able to write simple queries in SQL, DB to pull backend data, analyse and paint a good picture of failures signature
* Strong data processing and analytical skills (JIRA, Six Sigma, JMP)
* Enthusiasm to get a hands on understanding of complex problems
* Ability to prioritize own tasks in a dynamic, fast paced environment to maximize effectiveness
* Innate attention to detail and organization
* AS9100/ISO9001 experience is a nice to have
* Able to read 2D mechanical drawings and interpret CTQs, FAIs and come up with sampling plan
* Any previous experience with CMM, Metrology instruments, Faro arm would be great
Compensation:
* At Skydio, our compensation packages for regular, full-time employees include competitive base salaries, equity in the form of stock options, and comprehensive benefits packages. Compensation will vary based on factors, including skill level, proficiencies, transferable knowledge, and experience. Relocation assistance may also be provided for eligible roles. The annual base salary range for this position is $147,000 - 200,000*. we believe that equity is the key to long-term financial growth, and we ensure all regular, full-time employees have the opportunity to significantly benefit from the company's success. Regular, full-time employees are eligible to enroll in the Company's group health insurance plans. Regular, full-time employees are eligible to receive the following benefits: Paid vacation time, sick leave, holiday pay and 401K savings plan. This position and all associated benefits are subject to applicable federal, state, and local laws, as well as the Company's policies and eligibility criteria.
* Compensation for certain positions may vary based on the position's location.
#LI-AM1
At Skydio we believe that diversity drives innovation. We have created a multidisciplinary environment that embraces the power of diverse perspectives to create elegant solutions for complex problems. We are committed to growing our network of people, programs, and resources to nurture an inclusive culture.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or other characteristics protected by federal, state or local anti-discrimination laws.
For positions located in the United States of America, Skydio, Inc. uses E-Verify to confirm employment eligibility. To learn more about E-Verify, including your rights and responsibilities, please visit *************************
How much does a quality manager earn in Manteca, CA?
The average quality manager in Manteca, CA earns between $77,000 and $197,000 annually. This compares to the national average quality manager range of $64,000 to $128,000.
Average quality manager salary in Manteca, CA
$124,000
What are the biggest employers of Quality Managers in Manteca, CA?
The biggest employers of Quality Managers in Manteca, CA are: