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  • Localization QA III

    PTR Global

    Quality assurance manager job in Cupertino, CA

    Localization QA III Duration: Contract We are seeking a skilled Localization QA III to join our team in Cupertino, California. In this role, you will assist in localization efforts, coordinate localization QA, work with vendor testers both locally and internationally, and collaborate with multiple team members within the internal team. You will be responsible for creating QA plans, supporting QA efforts in the localization lab, fixing bugs, and ensuring the delivery of high-quality localized products in up to 40 languages simultaneously. The ideal candidate will have the ability to quickly identify and escalate issues while effectively communicating status updates to management. Responsibilities: Create and execute QA plans for localization projects. Support QA efforts in the localization lab. Identify, track, and resolve bugs to ensure high-quality localized products. Coordinate with vendor testers locally and internationally. Collaborate with internal team members to meet project deadlines. Effectively communicate project status and escalate issues as needed. Qualifications: Solid understanding of Localization Workflows, Software Development, and Software QA. Experience with content management databases and localization tools. Proven record of localization project management, testing, and bug tracking. Outstanding organizational and time-management skills. Ability to work independently in a global team environment. Excellent written and verbal cross-functional communication skills. Experience managing and delivering multiple projects within tight timeframes. High level of focus and meticulous attention to detail. Ability to identify and prioritize key deliverables and address blockers promptly. Flexibility, strong organizational skills, and adaptability to changing directions. Inventiveness, analytical skills, and a strong drive to learn and succeed. Preferred Skills: Competence working on iOS, mac OS, and other platforms, with familiarity with client products and services. Experience with scripting in Python and JavaScript. Native-level fluency in one or more languages besides English. Education and Experience: Bachelor's degree or equivalent experience in localization or QA. About PTR Global: PTR Global is a leading provider of information technology and workforce solutions. PTR Global has become one of the largest providers in its industry, with over 5000 professionals providing services across the U.S. and Canada. For more information visit ***************** At PTR Global, we understand the importance of your privacy and security. We NEVER ASK job applicants to: Pay any fee to be considered for, submitted to, or selected for any opportunity. Purchase any product, service, or gift cards from us or for us as part of an application, interview, or selection process. Provide sensitive financial information such as credit card numbers or banking information. Successfully placed or hired candidates would only be asked for banking details after accepting an offer from us during our official onboarding processes as part of payroll setup. Pay Range: $50 - $55 The specific compensation for this position will be determined by a number of factors, including the scope, complexity and location of the role as well as the cost of labor in the market; the skills, education, training, credentials and experience of the candidate; and other conditions of employment. Our full-time consultants have access to benefits including medical, dental, vision and 401K contributions as well as any other PTO, sick leave, and other benefits mandated by appliable state or localities where you reside or work. If you receive a suspicious message, email, or phone call claiming to be from PTR Global do not respond or click on any links. Instead, contact us directly at ***************. To report any concerns, please email us at ******************* GC1
    $50-55 hourly 5d ago
  • Manager, Hardware Quality Assurance

    Nvidia 4.9company rating

    Quality assurance manager job in Santa Clara, CA

    NVIDIA has been transforming computer graphics, PC gaming, and accelerated computing for more than 25 years. It's a unique legacy of innovation that's fueled by great technology-and amazing people. Today, we're tapping into the unlimited potential of AI to define the next era of computing. An era in which our GPU acts as the brains of computers, robots, and self-driving cars that can understand the world. Doing what's never been done before takes vision, innovation, and the world's best talent. As an NVIDIAN, you'll be immersed in a diverse, supportive environment where everyone is inspired to do their best work. Come join the team and see how you can make a lasting impact on the world! Are you equipped to tackle a highly ambitious position within a top-tier team? NVIDIA is on the lookout for a dynamic Team Manager to join our engineering team in Santa Clara, CA. Lead our Hardware Quality Assurance team to ensure outstanding quality and performance of our innovative hardware products! What you'll be doing: Coordinate pre-silicon emulation testing and assist software teams in identifying hardware issues at an early stage. Manage motherboard and display chipset interoperability testing, ensuring seamless integration of components, including strict USB-C compatibility checks. Coordinate PCI-SIG plugfest testing for PCI Express compliance, enabling the incorporation of NVIDIA GPUs in the Integrator's List. Meet the requirements of VESA and HDMI audio/video specifications by performing in-depth testing and validation processes. Supervise engagement during VESA and HDMI Forum plugfests, rapidly and proficiently handling display compatibility challenges. Participate in specification review meetings for compliance testing subgroups like PCIE, CXL, HDMI Forum, and VESA. Ensure the quality of firmware and diagnostics through manual evaluations at each engineering breakthrough and supervise Automated Regression Farms for consistent quality verifications. What we need to see: Bachelor's degree or equivalent experience in Electrical Engineering, Computer Engineering, or a related field. 3+ years experience managerial experience and hardware quality assurance 8+ years overall experience Strong knowledge of hardware testing methodologies and compliance standards. Excellent leadership, communication, and organizational skills. Ability to work collaboratively with cross-functional teams and external partners. Diligent with a strong focus on quality and continuous improvement. Ways to stand out from the crowd: Master's degree in a related field or equivalent experience. Experience with NVIDIA hardware and software products. Familiarity with PCI-SIG, VESA, HDMI Forum, and other industry standards is a must. Your base salary will be determined based on your location, experience, and the pay of employees in similar positions. The base salary range is 184,000 USD - 287,500 USD. You will also be eligible for equity and benefits. Applications for this job will be accepted at least until October 6, 2025.NVIDIA is committed to fostering a diverse work environment and proud to be an equal opportunity employer. As we highly value diversity in our current and future employees, we do not discriminate (including in our hiring and promotion practices) on the basis of race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law.
    $158k-206k yearly est. Auto-Apply 60d+ ago
  • Customer Quality Manager

    Amphenol Corporation 4.5company rating

    Quality assurance manager job in Santa Clara, CA

    Customer Quality Manager- HSIO CN Amphenol High Speed Products Group is the market leader for high speed, high bandwidth electrical connectors for the Telecom/Datacom market (Mobile Networks, Storage, Servers, Routers, Switches, etc.). Our products help to enable the electronics revolution and remain a key enabler for all the major Tier 1 OEMs globally. We are currently seeking a Customer Quality Manager to join our team. The position will be located in Santa Clara, California and will require a high level of direct customer interaction. RESPONSIBILITIES: Manage product and process quality, with a primary focus on new product introduction as well as legacy volume production, to meet customer satisfaction and business unit metrics. Responsible for managing all quality related aspects of customer relationships, including corrective action processes. This person will be the primary contact for customers regarding quality concerns and the required improvement plans that Amphenol needs to drive to address those concerns. Lead efforts to address and resolve customer quality issues in collaboration with internal teams. Drive customer quality related communication and presentations. Monitor and analyze quality related data with site level quality engineers or quality managers and make recommendations for improvement activities at all manufacturing locations, driving measurable results aligned to business level goals. Manage customer quality requirements through documentation review, process capability/control review with manufacturing locations, and participating in development engineering phase gate management review activities. Responsible for business unit level customer quality metrics and improvement initiatives; involves monthly reporting and review with the BU leadership team. Develop and implement quality training initiatives for customers and their respective programs. Perform initial and ongoing assessment of quality events at OEM / CM facilities as required Travel up to 50% QUALIFICATIONS: BS in Engineering, or an equivalent mix of education and experience. 5+ years of experience in manufacturing operations. Quality management experience with strong supervisory and leadership skills. Working knowledge and proven leadership in continuous improvement activities and formal quality management programs (DMAIC and 8D). Six Sigma Green Belt or Black Belt (preferred). Understanding of product documentation and technical drawings with emphasis on GD&T. Knowledgeable in semiconductor and interconnect industry manufacturing processes and standards Good communication and customer interface skills. The base salary range for this position is $100,000 - $189,260. In determining rate of pay, Amphenol considers a variety of nondiscriminatory factors, including but not limited to geographic location, relevant industry experience, qualifications, skills, and education. It would be rare for an individual to be hired at or near the top of the range for a given role. Base salary is one facet of Amphenol's total rewards package which includes participation in our comprehensive benefits program with medical, dental, and vision benefits effective day 1, vacation, sick leave, personal days, paid holidays, life insurance, short/long term disability, and matching 401K. Amphenol Corporation is proud of our reputation as an excellent employer. Our main focus is to provide the highest level of support and responsiveness to both our employees and our customers, the world's largest technology companies. Amphenol Corporation offers the opportunity for career growth within a global organization. We believe that Amphenol Corporation is unique in that every employee, regardless of his or her position, has the ability to positively impact the business. Amphenol is an "Equal Opportunity Employer" - Minority/Female/Disabled/Veteran/Sexual Orientation/Gender Identity/National Origin For additional company information please visit our website at ****************************
    $100k-189.3k yearly 5d ago
  • Director, Quality Assurance (Pharma)

    Adeptsource

    Quality assurance manager job in Redwood City, CA

    Title: Director, Quality Assurance, Pharma Type of role: FTE, Full time Salary: plus bonus and equity Our start-up Biotech client is seeking an Associate Director / Director Quality Assurance to join their growing company. Ideal candidate will be a hands-on Director who brings broad QA experience in the biologics industry. Job Description Develop and implement GXP including GMP quality systems in accordance with ICH, FDA, EMA and global competent authority regulations and industry guidance Review all GXP documents/reports especially as they relate to method development, validation activities and PPQ generation results Provide compliance oversight for internal and contracted external GXP activities Coordinate and implement audit plans and audit reports for all CROs, CDMOs, and GMP vendors and internal departments. Coordinate and perform virtual or on-site audits as needed Provide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition. Lead and ensure inspection readiness activities for all internal and external entities Host GMP inspections. Follow up to any responses and CAPAs Develop, implement, and manage the quality management systems including vendor management, change control, product label review, risk management, GXP computer systems, deviation and CAPA systems Develop and implement overall GXP strategy, performance metrics, analytics, and reports Ensure and record periodic SOP trainings for all employees including onboarding FTEs and contractors in the GXP system as applicable Qualifications Bachelor's degree in biological sciences or related field with minimum of 10 years' experience in a pharmaceutical setting. Proven, extensive knowledge of worldwide GXP regulatory requirements, industry practices, and ability to apply concepts. Experience with GMP regulations and current industry standards. Experience in designing and implementing quality systems and risk management tools Experience interacting with and managing CMOs for DS and DP especially biological products Experience leading/hosting US and international health authority inspections/interactions Excellent interpersonal, verbal, and written communication skills are critical in our collaborative work environment Must demonstrate high organizational, prioritization and management proficiencies Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities
    $149k-235k yearly est. 60d+ ago
  • Director, GCP Quality Assurance

    Septerna

    Quality assurance manager job in South San Francisco, CA

    Job Description Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date. We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team. We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment. For more information see: ***************** THE ROLE We are seeking an experienced, dynamic, and results-driven Associate Director / Director of GCP Quality Assurance our on-site team in South San Francisco. This role is critical in providing both strategic and operational quality oversight of clinical studies and vendor programs, ensuring compliance with ICH GCP and global regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will collaborate closely with clinical study teams and cross-functional partners, fostering a culture of quality and maintaining a state of continual GCP compliance across all programs. Responsibilities: Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements, and Septerna standards. Ensure clinical trials are conducted in accordance with GCP principles, producing high-quality and reliable data. Evaluate clinical trial documentation, study processes, and operational plans to confirm alignment with Septerna expectations and applicable regulations. Interpret and apply clinical and regulatory compliance requirements to support Septerna's objectives and ensure effective implementation across programs. Collaborate with clinical study teams to provide vendor quality oversight, identify and assess risks, and recommend appropriate remediation actions. Develop and execute GCP audit plans for assigned clinical studies as part of ongoing quality oversight. Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP. Work with cross-functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety. Assist in periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Septerna. Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders. Qualifications Bachelor's degree in life sciences or a related field; an advanced degree is preferred. 8-10 years of professional experience in Quality Assurance within the biopharmaceutical industry, with progressive responsibilities in Clinical QA. Minimum of 6 years of direct GCP audit experience, including investigator sites, CROs, and other clinical vendors. Proven ability to evaluate the effectiveness of CAPAs and follow up on audit findings to ensure timely and complete resolution. Strong knowledge of ICH GCP and applicable global regulatory requirements governing clinical research. Demonstrated experience providing GCP oversight of clinical studies and vendor programs. Skilled in authoring and revising SOPs, implementing process improvements, and ensuring quality systems remain phase-appropriate and fit-for-purpose. Demonstrated ability to assess compliance risks, interpret regulations, and implement practical, risk-based quality solutions. Excellent collaboration and communication skills with the ability to work effectively across functional areas and external partners. Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment. The anticipated salary range for candidates who will work in South San Francisco, CA is $220,000 - $240,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Septerna participates in the E-Verify program. California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice.
    $220k-240k yearly 8d ago
  • QA Lead/Architect/Manager with Bobcast

    360 It Professionals 3.6company rating

    Quality assurance manager job in Santa Clara, CA

    We are focused on imparting effective business staffing services through high level cost effective solutions. We have a strong foundation built on legacy and emerging technologies, including excellent track record of on-time delivery. We are leaders in providing additional custom IT Services with a proficient approach towards development of emerging mobile-based applications and web based application development. We are emerging as one of the largest private talent sourcing and management firms in the US Job Description We have an urgent requirement of QA consultant with Bobcat Automation Framework must Additional Information All your information will be kept confidential according to EEO guidelines.
    $133k-171k yearly est. 60d+ ago
  • Director of Quality Assurance

    Zenflow Inc. 3.7company rating

    Quality assurance manager job in South San Francisco, CA

    About Zenflow Zenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is an investigational device and is not approved for commercial sale. POSITION OVERVIEW: The Director of Quality Assurance provides strategic direction, management, and alignment of quality functions to ensure overall compliance with applicable national and international regulations, standards and best practice including FDA QSR, ISO 13485, and EU MDD. MAJOR DUTIES AND RESPONSIBILITIES: * Serves as Management Representative * Hosts FDA and regulatory agencies' quality system audits * Sets up Quality System policies and procedures to ensure compliance with FDA QSR, ISO 13485, and EU MDD requirements * Routinely evaluates the existing quality system to identify opportunities to streamline processes, and to ensure compliance with FDA QSR, ISO 13845, and MDD * Writes quality objectives * Manages quality resources, including personnel, equipment and budget in alignment with departmental and corporate goals * Performs Management Reviews and advise management of any product or process related issues and makes recommendations for improvements. * Plans and manages internal audit activities and coordinates audit corrective actions * Manages the quality group to ensure effective development and implementation of the Quality System Processes * Performs other duties as assigned EDUCATION REQUIREMENTS: Requires BS in a scientific or engineering discipline. EXPERIENCE REQUIREMENTS: Minimum of 10 years of Quality Assurance experience in the medical device industry. Minimum of 5 years of supervisory experience. OTHER QUALIFICATIONS: Requires written and verbal communication and interpersonal skills. Ability to communicate and interact with individuals at all levels of responsibility. This position is based in South San Francisco, CA. The expected salary range for this position is $190,000 - $225,000 , plus comprehensive benefits and equity. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.
    $190k-225k yearly 20d ago
  • Quality Assurance Ops Technical Manager

    Us Tech Solutions 4.4company rating

    Quality assurance manager job in Sunnyvale, CA

    + As a program manager, you will be responsible for quality assurance for a portfolio of workflows. + This includes everything from building out quality assurance processes, to monitoring the quality, to analyzing and addressing error trends. **Responsibilities:** + Execute on the quality roadmap for a portfolio of workflows, working with cross-functional partners. + Drive execution for each quality implementation, track schedule or milestones, flag risks, resolve issues, and manage escalations. + Coordinate with stakeholders to ensure alignment on new processes, training on tooling or error categorization, UAT, launch readiness, etc. + Provide thorough, easy to consume documentation of quality implementations. + Monitor and report on quality for a portfolio of workflows, working closely with vendor partners and cross-functional partners to flag and address error trends. **Requirements:** + Proven track record of documenting technical implementations. + Collaborate with technical staff for the technical aspects of quality monitoring including managing bug fixes. **Experience:** + 4+ years of cross-functional project management experience. + Strong communication and collaboration skills. + Excellent problem-solving, critical thinking, and analytical skills. **Skills:** + SQL knowledge with experience working with multiple large datasets. + Content moderation knowledge and/or experience with quality assurance. **Education:** + BA/BS degree. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (*********************************** . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
    $108k-157k yearly est. 60d+ ago
  • Quality Manager / Metallurgist

    United States Pipe and Foundry Company, Inc. 4.5company rating

    Quality assurance manager job in Union City, CA

    Why Join Our Team? Do you want to be part of a team that is making a positive difference in lives all across the globe? Do you want to be part of a culture where you are recognized, respected, and rewarded for a job well done? U.S. Pipe has been providing quality water and wastewater products since 1899, and for the past 120 years we have proudly supported local governments, municipalities, water departments, and businesses all across the United States, and the world. What We Offer: * Team Collaboration: Join a team-oriented environment where collaboration is not just a buzzword but a priority. * Career Growth: Be part of an industry leader renowned for world-class design, manufacturing, sourcing, and distribution, and take your career to the next level. * Comprehensive Benefits: We provide a comprehensive benefits package with options tailored to meet your needs and those of your family. Job Description: U.S. Pipe and Foundry is seeking a Quality Manager Metallurgist. This role will play a pivotal role in planning, managing and directing the Quality Management System and Quality Assurance to ensure that products meet or exceed national and/or international industry standards, company standards, and specifications provided according to customer requirements. Key metrics will be safety, quality, delivery, and cost vs. plan. Essential Functions: * Supervises the work of Quality Assurance exempt, nonexempt and hourly employees to assure that the products meet customers' requirements when shipped, comply with company, industry, national and/or international standards. * Assures that material certifications and other quality documents are accurate and issued as required. * Provides leadership in the development and implementation of process control plans designed to reduce internal defects and to offset weaknesses in performance. * Takes a leadership role with production and other personnel to assure that quality issues are resolved in a timely and efficient manner; with the intent of moving toward a quality performance level substantially free of defects that result in scrap, rework or field failures. * Monitors, reviews and evaluates daily, weekly and monthly production, cost, labor and material usage data; identifies problems, develops, implements, and maintains the corrective and preventive action system. * Implements and maintains an ISO 9001 compliant quality management system that is focused on continual improvement of all processes and functions; directs the development and revision of quality management system procedures, work instructions and controls distribution at the plant level including plant distribution of corporate quality documents. * Investigates and manages customer complaints; reports status of complaints and the overall quality system including corrective actions, audits and follow-up activities to plant and corporate management. * Assures that all plant and safety rules and policies are enforced and that violators are constructively disciplined in a fair and consistent manner; assists supervision with daily administration of the collective bargaining agreement and attends grievance and other employee meetings as required. * Assures that both supervisory and hourly employees are properly trained and qualified, identifying training and development needs and assisting in the design and implementation of programs to meet these needs. * Serves as plant representative for on-site customer visits and inspections. * As a member of the Plant leadership team, meets regularly with other staff members to formulate and discuss means of achieving Company quality goals. * Perform other duties as assigned. * As for all employee, this individual is expected to demonstrate our core values: customer commitment, high-performance culture, fleet of foot, innovation, accountability, integrity, respect for others and teamwork. Skills and Other Requirements: * Bachelor's Degree in Metallurgical Engineering, Material Science, Chemical Engineering, and/or related field is required. Master's Degree is a plus. * A minimum of 5 - 7 years of supervisory or management and quality assurance experience in a fast-paced heavy union or non-union manufacturing environment and advanced knowledge of, and experience in, quality management systems are required. * Previous foundry knowledge around melting, casting, annealing, inspection and testing procedures is required. * Proven management leadership experience is required. * Ability to plan and direct the work of salaried supervisory and hourly personnel and to train and develop the workforce in quality principles/techniques. * Training and experience leading quality assurance initiatives such as ISO and 8D problem solving methodology. * Strong leadership and team building skills. * Strong oral and written communication skills. * Strong analytical and problem-solving skills. * Strong presentation and public speaking skills. * Ability to prioritize and manage multiple tasks/projects and meet all required deadlines. * Strong sense of urgency in meeting customer needs. * Good understanding of safety and the desire to follow all established procedures are required. * Must have strong working knowledge of Microsoft Excel, Word, Outlook and PowerPoint software. * Previous SAP, Minitab, and SharePoint knowledge is a
    $101k-152k yearly est. 2d ago
  • Director, Quality Assurance (QA)

    Targetcw Sandbox

    Quality assurance manager job in Mountain View, CA

    About the Company: Our client is a leading venture backed pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Their products are designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner. This is a great opportunity to get introduced to a growing Bay Area Pharma company and learn new processes. Job Description Title: Director, Quality Assurance (QA) Location: Mountain View, CA 94043 Salary: $185,000+ Dependent on Experience Direct Hire Job Responsibilities: Lead all Quality Assurance functions for both commercial and clinical products manufacturing and development Lead the development, implementation and maintenance of quality systems and related activities to ensure compliance to applicable regulatory requirements (e.g., deviations/CAPA process, Change Control and documents management, Quality procedures, validation program, product complaints program, and selection, evaluation and oversight of suppliers and service providers Lead effort to develop phase-appropriate Quality Systems Lead CCB and MRB meetings Schedule and participate in external and internal audits Responsible for materials and product lot release Serve as primary interface with Regulatory Agency inspectors during GMP inspections Serve as primary interface on Quality Assurance matters with corporate partners and Ferrer Quality unit Responsible for Quality Management Reviews Responsible for Product Quality Review report Responsible for development and management of departmental budget Provides mentorship to staff Qualifications and Experience: BS in Life Sciences, Chemistry or related science disciplines 10+ years Quality Assurance experience in pharmaceutical and/or medical device industry Experience in drug/device combination products is a plus, and experience in inhalation products is highly desirable Comprehensive knowledge of cGMP regulations (US and EU), Quality Systems, ISO, and SOPs applicable to pharmaceutical and/or medical device organizations Excellent verbal and written communication skills Strong leadership ability, both within department and in cross-functional team settings Ability to execute as well as lead Ability to exercise judgment within broadly defined practices and policies to evaluate and solve problems Solid understanding of pharmaceutical and medical device development Please submit an updated version of your resume for immediate and confidential consideration. Thank you! Qualifications Qualifications and Experience: BS in Life Sciences, Chemistry or related science disciplines 10+ years Quality Assurance experience in pharmaceutical and/or medical device industry Experience in drug/device combination products is a plus, and experience in inhalation products is highly desirable Comprehensive knowledge of cGMP regulations (US and EU), Quality Systems, ISO, and SOPs applicable to pharmaceutical and/or medical device organizations Excellent verbal and written communication skills Strong leadership ability, both within department and in cross-functional team settings Ability to execute as well as lead Ability to exercise judgment within broadly defined practices and policies to evaluate and solve problems Solid understanding of pharmaceutical and medical device development Please submit an updated version of your resume for immediate and confidential consideration. Thank you! Additional Information Please submit an updated version of your resume for immediate and confidential consideration. Thank you!
    $185k yearly 14h ago
  • Director, Quality Assurance and Regulatory Affairs

    Noah Homes 4.1company rating

    Quality assurance 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
  • Head of Manufacturing Quality

    Zipline 4.7company rating

    Quality assurance manager job in South San Francisco, CA

    Do you want to change the world? Zipline is on a mission to transform the way goods move. Our aim is to solve the world's most urgent and complex access challenges by building, manufacturing, and operating the first instant delivery and logistics system that serves all humans equally, wherever they are. From powering Rwanda's national blood delivery network and Ghana's COVID-19 vaccine distribution, to providing on-demand home delivery for Walmart, to enabling healthcare providers to bring care directly to U.S. homes, we are transforming the way things move for businesses, governments, and consumers. The technology is complex, but the idea is simple: a teleportation service that delivers what you need, when you need it. Through robotics and autonomy, we are decarbonizing delivery, decreasing road congestion, reducing fossil fuel consumption and air pollution, while building a more resilient global supply chain. About You and the Role Are you a hands-on, systems-level thinker who thrives at the intersection of technical rigor, operational excellence, and team leadership? Do you love building and scaling quality systems that ensure products meet the highest standards of reliability, safety, and performance-without slowing innovation? As Head of Quality, you will lead Zipline's Quality organization-including our Quality Engineers and Quality Technicians-overseeing the end-to-end quality lifecycle across all feeder lines and top-level assemblies: aircraft, droid, and dock. You will own the quality strategy, execution, and continuous improvement across Incoming Quality Control (IQC), End-of-Line (EOL), and Outgoing Quality Control (OQC) processes to ensure every Zipline product meets the performance and reliability expectations required for global operations. This role is both strategic and deeply operational. You'll develop scalable quality processes, coach and empower a high-performing team, and use data to drive continuous improvement in first pass yield (FPY), cost of poor quality (COPQ), and field reliability. As a key manufacturing leader, you'll collaborate closely with Production, Manufacturing Engineering, Supply Chain, and Product Design to ensure quality is built into every stage-from supplier through shipment. You'll need to be comfortable operating in an ambiguous, rapidly evolving environment, balancing day-to-day problem solving with building long-term systems that will scale as Zipline grows globally. What You'll Do As Head of Quality, you'll define and drive Zipline's quality vision and roadmap across production and field operations. You'll empower your team to execute with precision, while building the systems, tools, and culture that enable sustained quality excellence. RESPONSIBILITIES: Lead and develop Zipline's Quality Engineering and Quality Technician teams, ensuring effective execution across IQC, EOL, and OQC functions. Define, implement, and continuously improve quality processes across top-level assemblies (aircraft, droid, dock) Establish and track key quality metrics including first pass yield, defect rates, rework hours, and field quality escapes (modifying these as scale changes) Drive cross-functional investigations for major production or field quality issues-owning containment, root cause analysis, corrective/preventive actions (CAPA), and communication to leadership. Drive PFMEAs for all products to be manufactured on the production lines to establish control plans and quality procedures Partner with Manufacturing Engineering, Supply Chain, and Product Design to implement design-for-quality (DFQ) and process control strategies that reduce variability and improve manufacturability. Oversee and optimize incoming inspection programs to ensure parts and subassemblies meet quality standards before entering production. Champion reliability improvement and validation testing at end-of-line to prevent downstream failures and quality escapes to the field. Own the overall Quality Management System (QMS) maturity roadmap-balancing rigor with practicality as the company scales. Lead continuous improvement initiatives focused on driving yield improvement, waste reduction, and process standardization. Build and foster a culture of accountability, root cause problem-solving, and pride in quality across the production floor. Serve as the senior quality voice in leadership reviews-providing transparency into risks, performance trends, and improvement priorities. Must Have Experience / Skill Sets 10+ years of experience in manufacturing quality, reliability, or production engineering, including 3+ years in a leadership role managing quality teams. Experience with scaling a quality system from low prototype production to low volume production (100/wk) to high volume production (1000s/wk) with complex electro-mechanical hardware (automotive, small aircraft, robotics, etc) Strong understanding of quality engineering tools and methodologies: PFMEA, control plans, and CAPA. Demonstrated success in scaling quality systems across complex electro-mechanical products. Hands-on experience in production environments managing inspection, testing, and validation activities. Proven ability to reduce quality escapes and improve first pass yield in high-mix, low- to mid-volume operations. Strong data analysis skills; comfortable using quality metrics to drive improvement and accountability. Experience collaborating closely with Manufacturing Engineering, Supply Chain, and Design Engineering teams to influence product and process quality. Excellent leadership and communication skills-capable of motivating teams and driving cross-functional alignment. Ability to balance hands-on problem solving with long-term strategic planning. Comfort operating in a fast-paced, ambiguous, and rapidly scaling environment. Nice to Have Experience in robotics or automotive manufacturing. Background in supplier quality and global production scaling. Familiarity with MES, ERP, and PLM systems for quality data traceability. Experience managing automated or semi-automated inspection systems. What Else You Need to Know Zipline is an equal opportunity employer and prohibits discrimination and harassment of any kind. We value diversity and welcome applications from those who are traditionally underrepresented in tech. If you like the sound of this position but are not sure if you are the perfect fit, please apply!
    $141k-219k yearly est. Auto-Apply 27d ago
  • SAP Quality Management/Manufacturing Manager - Chemicals Industry

    Accenture 4.7company rating

    Quality assurance manager job in Mountain View, CA

    We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational. As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement You Are: Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction? Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds. Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them. The Work: Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to: + Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future) + Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations + Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions + Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation. + Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture + Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise + Be a thought leader, build assets and best practices and develop the next level of transformation experts Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements Here's what you need: + Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing. + Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement) + Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients + Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area + Prior experience in a Consulting and/or Advisory role + Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. (************************************************************ Role Location Annual Salary Range California $94,400 to $293,800 Cleveland $87,400 to $235,000 Colorado $94,400 to $253,800 District of Columbia $100,500 to $270,300 Illinois $87,400 to $253,800 Maryland $94,400 to $253,800 Massachusetts $94,400 to $270,300 Minnesota $94,400 to $253,800 New York/New Jersey $87,400 to $293,800 Washington $100,500 to $270,300 Requesting an Accommodation Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at **************** or send us an email or speak with your recruiter. Equal Employment Opportunity Statement We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. For details, view a copy of the Accenture Equal Opportunity Statement (******************************************************************************************************************************************** Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities. Accenture is committed to providing veteran employment opportunities to our service men and women. Other Employment Statements Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States. Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration. Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information. California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information. Please read Accenture's Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.
    $100.5k-270.3k yearly 21d ago
  • Program Manager, Product Quality and Readiness

    Rivian 4.1company rating

    Quality assurance manager job in San Jose, CA

    About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we constantly challenge what's possible, never simply accepting what has always been done. We reframe old problems, seek new solutions and operate comfortably in areas that are unknown. Our backgrounds are diverse, but our team shares a love of the outdoors and a desire to protect it for future generations. Role Summary At Rivian, handing over the keys isn't just a transaction; it is the start of an adventure. As the Program Manager, Product Quality & Readiness, you are the guardian of that standard. You are a strategic operator and systems thinker obsessed with defining the technical frameworks and quality gates that ensure every vehicle delivered to a customer is flawless in both function and form. You operate at the critical junction where the factory ends and the customer journey begins. Your mission is to architect the intelligent, scalable operating system that performs the final validation of our vehicles before they ever reach a customer's driveway. You ensure that the first moment of ownership is pure joy, unmarred by technical oversight or cosmetic imperfection. More critically, you will transform this validation phase into the ultimate feedback loop. You will capture high-fidelity data to drive systemic improvements in the factory, while simultaneously driving rigorous operational execution in the field to ensure vehicle presentation is immaculate. You are the operational bridge ensuring quality is a closed-loop system that centers the customer at every stage. Responsibilities The Customer Advocate: You never lose sight of the human being waiting for their keys. You view every defect-whether a software bug or a smudge on the glass-as a potential friction point in a customer's adventure, and you fight relentlessly to eliminate them. The Clarity Creator: You are an expert at simplifying complex quality challenges into structured, measurable technical programs. The Data Architect: You use data to diagnose systemic issues, build compelling business cases, and ensure every requirement is backed by measurable field impact. The Strategic Partner: You excel at translating field reality into actionable HQ plans, fostering alignment and shared success with central teams, especially Manufacturing. A Long-Term Builder: You are focused on building sustainable, scalable systems that will power our quality standards for years to come. Qualifications 8+ years of experience in Technical Program Management, Product, Process/Industrial Engineering, or Operations within a complex hardware-intensive industry (Automotive, Aerospace, or similar). This requirement is reduced to 5 years for candidates with a Master's degree. Customer Obsession: A demonstrated ability to connect technical processes to customer outcomes. You understand that "Quality" is defined by the user experience, not just the spec sheet. Operational Rigor: Experience defining Standard Operating Procedures (SOPs) for field or factory teams. You understand that while the factory builds the product, the field team delivers the experience, and you know how to drive compliance in product presentation, quality, and cleanliness. Proven experience in defining, deploying, and owning technical systems and data pipelines, specifically around quality control, manufacturing execution (MES), or diagnostic tooling. Exceptional ability to synthesize high-volume data (telemetry, manufacturing data) into clear, strategic narratives for both executive and engineering audiences. The Operator-Engineer Mindset: You are equal parts operator (focused on execution, logistics, and people) and engineer (focused on systems, optimization, and tools). Applied Ingenuity: A degree in a hands-on technical field is preferred. However, we value applied ingenuity above all; a demonstrated track record of solving complex problems in rigorous environments may be accepted in lieu of specific academic credentials. Pay Disclosure Salary Range/Hourly Rate for California Based Applicants: $121,800 - $161,450 (actual compensation will be determined based on experience, location, and other factors permitted by law). Benefits Summary: Rivian provides robust medical/Rx, dental and vision insurance packages for full-time and part-time employees, their spouse or domestic partner, and children up to age 26. Full Time Employee coverage is effective on the first day of employment. Part-Time employee coverage is effective the first of the month following 90 days of employment. Salary Range/Hourly Rate for Illinois Based Applicants: $102,300 - $135,580 (actual compensation will be determined based on experience, location, and other factors permitted by law). Benefits Summary: Rivian provides robust medical/Rx, dental and vision insurance packages for full-time and part-time employees, their spouse or domestic partner, and children up to age 26. Full Time Employee coverage is effective on the first day of employment. Part-Time employee coverage is effective the first of the month following 90 days of employment. Equal Opportunity Rivian is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, gender, gender expression, gender identity, genetic information or characteristics, physical or mental disability, marital/domestic partner status, age, military/veteran status, medical condition, or any other characteristic protected by law. Rivian is committed to ensuring that our hiring process is accessible for persons with disabilities. If you have a disability or limitation, such as those covered by the Americans with Disabilities Act, that requires accommodations to assist you in the search and application process, please email us at candidateaccommodations@rivian.com. Candidate Data Privacy Rivian may collect, use and disclose your personal information or personal data (within the meaning of the applicable data protection laws) when you apply for employment and/or participate in our recruitment processes ("Candidate Personal Data"). This data includes contact, demographic, communications, educational, professional, employment, social media/website, network/device, recruiting system usage/interaction, security and preference information. Rivian may use your Candidate Personal Data for the purposes of (i) tracking interactions with our recruiting system; (ii) carrying out, analyzing and improving our application and recruitment process, including assessing you and your application and conducting employment, background and reference checks; (iii) establishing an employment relationship or entering into an employment contract with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v) recordkeeping; (vi) ensuring network and information security and preventing fraud; and (vii) as otherwise required or permitted by applicable law. Rivian may share your Candidate Personal Data with (i) internal personnel who have a need to know such information in order to perform their duties, including individuals on our People Team, Finance, Legal, and the team(s) with the position(s) for which you are applying; (ii) Rivian affiliates; and (iii) Rivian's service providers, including providers of background checks, staffing services, and cloud services. Rivian may transfer or store internationally your Candidate Personal Data, including to or in the United States, Canada, the United Kingdom, and the European Union and in the cloud, and this data may be subject to the laws and accessible to the courts, law enforcement and national security authorities of such jurisdictions. Please note that we are currently not accepting applications from third party application services. 8+ years of experience in Technical Program Management, Product, Process/Industrial Engineering, or Operations within a complex hardware-intensive industry (Automotive, Aerospace, or similar). This requirement is reduced to 5 years for candidates with a Master's degree. Customer Obsession: A demonstrated ability to connect technical processes to customer outcomes. You understand that "Quality" is defined by the user experience, not just the spec sheet. Operational Rigor: Experience defining Standard Operating Procedures (SOPs) for field or factory teams. You understand that while the factory builds the product, the field team delivers the experience, and you know how to drive compliance in product presentation, quality, and cleanliness. Proven experience in defining, deploying, and owning technical systems and data pipelines, specifically around quality control, manufacturing execution (MES), or diagnostic tooling. Exceptional ability to synthesize high-volume data (telemetry, manufacturing data) into clear, strategic narratives for both executive and engineering audiences. The Operator-Engineer Mindset: You are equal parts operator (focused on execution, logistics, and people) and engineer (focused on systems, optimization, and tools). Applied Ingenuity: A degree in a hands-on technical field is preferred. However, we value applied ingenuity above all; a demonstrated track record of solving complex problems in rigorous environments may be accepted in lieu of specific academic credentials. The Customer Advocate: You never lose sight of the human being waiting for their keys. You view every defect-whether a software bug or a smudge on the glass-as a potential friction point in a customer's adventure, and you fight relentlessly to eliminate them. The Clarity Creator: You are an expert at simplifying complex quality challenges into structured, measurable technical programs. The Data Architect: You use data to diagnose systemic issues, build compelling business cases, and ensure every requirement is backed by measurable field impact. The Strategic Partner: You excel at translating field reality into actionable HQ plans, fostering alignment and shared success with central teams, especially Manufacturing. A Long-Term Builder: You are focused on building sustainable, scalable systems that will power our quality standards for years to come.
    $121.8k-161.5k yearly Auto-Apply 2d ago
  • Quality Manager, Supplier QA

    Veracyte 4.6company rating

    Quality assurance manager job in South San Francisco, CA

    At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a purpose driven environment. This is what we call the Veracyte way - it's about how we work together, guided by our values, to give clinicians the insights they need to help patients make life-changing decisions. Our Values: We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins We Care Deeply: We embrace our differences, do the right thing, and encourage each other The Position: As the Quality Manager, Supplier QA you will lead the qualification, monitoring, and oversight of Veracyte's Contract Manufacturers (CMOs) and IVD suppliers. You will serve as the primary quality interface between Veracyte and its external manufacturing partners, ensuring that all products and processes meet applicable regulatory requirements (e.g., ISO 13485, FDA QSR, IVDR) and internal quality standards. The ideal candidate brings strong supplier quality experience, auditing, and managing external manufacturing relationships. This is a hybrid role (remote and in office up to 3 days a week as necessary) and is based out of our headquarters in South San Francisco (SSF), California, United States. Responsibilities: Own and lead the Supplier Quality Management to ensure vendor products, processes and services are provided in compliance with applicable regulations (e.g., FDA, ISO 13485, EU IVDR, etc.) and Veracyte's quality standards. Establish and maintain supplier and CMO oversight strategies, including risk-based qualification, periodic performance monitoring, and quality metrics. Serve as the primary Quality lead for supplier and CMO relationships, providing quality input during supplier selection, qualification, and issue resolution. Lead and execute supplier audits, ensure timely closure of audit findings, and drive continuous improvement across the supplier base. Develop, implement, and maintain supplier quality metrics and monitoring programs. Lead investigations of supplier and CMO related quality incidents, perform root cause analysis, assess impact on product or regulatory compliance Oversee and maintain the Approved Supplier List (ASL) and associated supplier documentation in compliance with ISO 13485 and IVDR. Lead suppliers and CMOs qualification activities, including risk assessments, audits, and quality agreements Issue, track, and close Supplier Corrective Action Requests (SCARs) related to supplier non-conformances Review and approve supplier change notifications and deviations to assess the impact on product quality and regulatory compliance. Ensure appropriate validation and verification activities are performed for supplier-initiated changes Collaborate cross-functionally with R&D, Regulatory Affairs, and Supply Chain to support new product introductions and design transfers to CMOs. Support regulatory inspections and notified body audits, serving as the SME for supplier quality. Champion continuous improvement initiatives to strengthen supplier quality processes and reduce external quality risk. Who You Are: Qualifications: Bachelor's degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field A minimum of 6 - 7 years of progressive experience in Quality Assurance within the medical device or IVD industry. In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and, ISO 14971:2019 risk management Prior experience in implementing and establishing a Supplier Quality program that is compliant to ISO13485 and IVDR requirements Demonstrated success in supplier quality leadership, audit execution, and external manufacturing oversight. Willingness to travel (up to ~30%) to supplier and CMO sites. Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses Strong organization skills to manage multiple simultaneous projects in a fast-paced environment. Attention to detail in understanding and documenting complex quality issues Highly organized, self-motivated, and comfortable working in a fast-paced IVD environment. ISO 13485 Lead Auditor or equivalent lead auditor certificate is preferred #LI-Hybrid The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to years of experience, skillset, geographic location, industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. Pay range$128,000-$149,000 USDWhat We Can Offer You Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are thrilled to be recognized as a 2024 Certified™ Great Place to Work in both the US and Israel - a testament to our dynamic, inclusive, and inspiring workplace where passion meets purpose. About Veracyte Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit **************** or follow us on LinkedIn or X (Twitter). Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E-Verify in the United States. View our CCPA Disclosure Notice. If you receive any suspicious alerts or communications through LinkedIn or other online job sites for any position at Veracyte, please exercise caution and promptly report any concerns to ********************
    $128k-149k yearly Auto-Apply 6d ago
  • Quality Control Manager

    The Bizzell Group 3.6company rating

    Quality assurance manager job in Mountain View, CA

    Bizzell is a management and consulting firm with a mission to improve lives and accelerate positive change. We deliver award-winning services to a diverse portfolio of clients to help build healthy, secure, and sustainable communities across the globe. Bizzell's multi-disciplinary team works in health solutions, workforce innovation, managed services, and global programs. Specifically, they offer expertise in program management, research and evaluation, communication and outreach, training and technical assistance, policy analysis, and development. At Bizzell, we are passionate about the work that we do and about the people we positively impact. Our vision, mission, and goals truly reflect our desire to make a real difference in this world. We want to work with people that share the same values, and we are hoping this could be you! Bizzell is seeking a Quality Control Manager at NASA AMES located in Mountainview, CA. This career opportunity is contingent upon the contract award. To be considered for this position, it may require a signed letter of intent. Duties/Responsibilities: Oversee the implementation of quality programs to provide maintenance and operations (M&O) support. Works closely with personnel who provides oversight and compliance of contract Quality requirements. Responsible for managing NASA AMES Operations Procedure Plan, and Contractor Technical Description Document (TDD), as assigned by Program Manager. Perform regular inspections of buildings, equipment, grounds, and operations to identify and keep accurate records of NASA AMES quality conditions. Assign and management internal non-conformance and corrective action reports. Quickly resolve and escalate issues that arise in a timely manner. Perform root cause analysis to identify corrective actions plans to support problem solutions. Effectively enforce quality standards and methodology. Communicate effectively verbal and written format with Bizzell, NASA AMES management team, and personnel. Diligently keeps everyone abreast of changes in quality issues, continuous improvement opportunities, and performance metrics within the organization. Education and Experience: U.S. Citizen and able to obtain a federal government clearance. Bachelor's degree in business administration required. Must have International Organization for Standardization (ISO) certification. 10 years of Quality Control Management experience required. Experienced in federal government contracting, ISO standards, quality metrics for maintenance and operations. Excellent time management and organizational skills. Ability to multi-task, prioritize, and complete work assignments in a timely manner. This position description should not be construed to imply that these requirements are the exclusive standards of the position, nor will these requirements be the sole basis for any subsequent employee evaluations. Equal Opportunities: Bizzell is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law.
    $70k-102k yearly est. 60d+ ago
  • Customer Quality Manager

    Amphenol Communication Solutions 4.5company rating

    Quality assurance manager job in Santa Clara, CA

    Customer Quality Manager- HSIO CN Amphenol High Speed Products Group is the market leader for high speed, high bandwidth electrical connectors for the Telecom/Datacom market (Mobile Networks, Storage, Servers, Routers, Switches, etc.). Our products help to enable the electronics revolution and remain a key enabler for all the major Tier 1 OEMs globally. We are currently seeking a Customer Quality Manager to join our team. The position will be located in Santa Clara, California and will require a high level of direct customer interaction. RESPONSIBILITIES: Manage product and process quality, with a primary focus on new product introduction as well as legacy volume production, to meet customer satisfaction and business unit metrics. Responsible for managing all quality related aspects of customer relationships, including corrective action processes. This person will be the primary contact for customers regarding quality concerns and the required improvement plans that Amphenol needs to drive to address those concerns. Lead efforts to address and resolve customer quality issues in collaboration with internal teams. Drive customer quality related communication and presentations. Monitor and analyze quality related data with site level quality engineers or quality managers and make recommendations for improvement activities at all manufacturing locations, driving measurable results aligned to business level goals. Manage customer quality requirements through documentation review, process capability/control review with manufacturing locations, and participating in development engineering phase gate management review activities. Responsible for business unit level customer quality metrics and improvement initiatives; involves monthly reporting and review with the BU leadership team. Develop and implement quality training initiatives for customers and their respective programs. Perform initial and ongoing assessment of quality events at OEM / CM facilities as required Travel up to 50% QUALIFICATIONS: BS in Engineering, or an equivalent mix of education and experience. 5+ years of experience in manufacturing operations. Quality management experience with strong supervisory and leadership skills. Working knowledge and proven leadership in continuous improvement activities and formal quality management programs (DMAIC and 8D). Six Sigma Green Belt or Black Belt (preferred). Understanding of product documentation and technical drawings with emphasis on GD&T. Knowledgeable in semiconductor and interconnect industry manufacturing processes and standards Good communication and customer interface skills. The base salary range for this position is $100,000 - $189,260. In determining rate of pay, Amphenol considers a variety of nondiscriminatory factors, including but not limited to geographic location, relevant industry experience, qualifications, skills, and education. It would be rare for an individual to be hired at or near the top of the range for a given role. Base salary is one facet of Amphenol's total rewards package which includes participation in our comprehensive benefits program with medical, dental, and vision benefits effective day 1, vacation, sick leave, personal days, paid holidays, life insurance, short/long term disability, and matching 401K. Amphenol Corporation is proud of our reputation as an excellent employer. Our main focus is to provide the highest level of support and responsiveness to both our employees and our customers, the world's largest technology companies. Amphenol Corporation offers the opportunity for career growth within a global organization. We believe that Amphenol Corporation is unique in that every employee, regardless of his or her position, has the ability to positively impact the business. Amphenol is an "Equal Opportunity Employer" - Minority/Female/Disabled/Veteran/Sexual Orientation/Gender Identity/National Origin For additional company information please visit our website at ****************************
    $100k-189.3k yearly 14d ago
  • AD/Director, Quality Assurance

    Adeptsource

    Quality assurance manager job in Redwood City, CA

    Title: AD/Director, Quality Assurance, Pharma Type of role: FTE, Full time Salary: 181K - 214K plus bonus and equity Our direct client is seeking an Associate Director / Director Quality Assurance to join their growing company. Job Description Develop and implement GXP including GMP quality systems in accordance with ICH, FDA, EMA and global competent authority regulations and industry guidance Review all GXP documents/reports especially as they relate to method development, validation activities and PPQ generation results Provide compliance oversight for internal and contracted external GXP activities Coordinate and implement audit plans and audit reports for all CROs, CDMOs, and GMP vendors and internal departments. Coordinate and perform virtual or on-site audits as needed Provide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition. Lead and ensure inspection readiness activities for all internal and external entities Host GMP inspections. Follow up to any responses and CAPAs Develop, implement, and manage the quality management systems including vendor management, change control, product label review, risk management, GXP computer systems, deviation and CAPA systems Develop and implement overall GXP strategy, performance metrics, analytics, and reports Ensure and record periodic SOP trainings for all employees including onboarding FTEs and contractors in the GXP system as applicable Qualifications Bachelor's degree in biological sciences or related field with minimum of 10 years' experience in a pharmaceutical setting. Proven, extensive knowledge of worldwide GXP regulatory requirements, industry practices, and ability to apply concepts. Experience with GMP regulations and current industry standards. Experience in designing and implementing quality systems and risk management tools Experience interacting with and managing CMOs for DS and DP especially biological products Experience leading/hosting US and international health authority inspections/interactions Excellent interpersonal, verbal, and written communication skills are critical in our collaborative work environment Must demonstrate high organizational, prioritization and management proficiencies Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities
    $149k-235k yearly est. 60d+ ago
  • Director, GCP Quality Assurance

    Septerna

    Quality assurance manager job in South San Francisco, CA

    Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date. We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team. We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment. For more information see: ***************** THE ROLE We are seeking an experienced, dynamic, and results-driven Associate Director / Director of GCP Quality Assurance our on-site team in South San Francisco. This role is critical in providing both strategic and operational quality oversight of clinical studies and vendor programs, ensuring compliance with ICH GCP and global regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will collaborate closely with clinical study teams and cross-functional partners, fostering a culture of quality and maintaining a state of continual GCP compliance across all programs. Responsibilities: Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements, and Septerna standards. Ensure clinical trials are conducted in accordance with GCP principles, producing high-quality and reliable data. Evaluate clinical trial documentation, study processes, and operational plans to confirm alignment with Septerna expectations and applicable regulations. Interpret and apply clinical and regulatory compliance requirements to support Septerna's objectives and ensure effective implementation across programs. Collaborate with clinical study teams to provide vendor quality oversight, identify and assess risks, and recommend appropriate remediation actions. Develop and execute GCP audit plans for assigned clinical studies as part of ongoing quality oversight. Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP. Work with cross-functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety. Assist in periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Septerna. Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders. Qualifications Bachelor's degree in life sciences or a related field; an advanced degree is preferred. 8-10 years of professional experience in Quality Assurance within the biopharmaceutical industry, with progressive responsibilities in Clinical QA. Minimum of 6 years of direct GCP audit experience, including investigator sites, CROs, and other clinical vendors. Proven ability to evaluate the effectiveness of CAPAs and follow up on audit findings to ensure timely and complete resolution. Strong knowledge of ICH GCP and applicable global regulatory requirements governing clinical research. Demonstrated experience providing GCP oversight of clinical studies and vendor programs. Skilled in authoring and revising SOPs, implementing process improvements, and ensuring quality systems remain phase-appropriate and fit-for-purpose. Demonstrated ability to assess compliance risks, interpret regulations, and implement practical, risk-based quality solutions. Excellent collaboration and communication skills with the ability to work effectively across functional areas and external partners. Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment. The anticipated salary range for candidates who will work in South San Francisco, CA is $220,000 - $240,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Septerna participates in the E-Verify program. California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice.
    $220k-240k yearly Auto-Apply 43d ago
  • Director of Quality Assurance

    Zenflow 3.7company rating

    Quality assurance manager job in South San Francisco, CA

    Zenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is an investigational device and is not approved for commercial sale. POSITION OVERVIEW: The Director of Quality Assurance provides strategic direction, management, and alignment of quality functions to ensure overall compliance with applicable national and international regulations, standards and best practice including FDA QSR, ISO 13485, and EU MDD. MAJOR DUTIES AND RESPONSIBILITIES: Serves as Management Representative Hosts FDA and regulatory agencies' quality system audits Sets up Quality System policies and procedures to ensure compliance with FDA QSR, ISO 13485, and EU MDD requirements Routinely evaluates the existing quality system to identify opportunities to streamline processes, and to ensure compliance with FDA QSR, ISO 13845, and MDD Writes quality objectives Manages quality resources, including personnel, equipment and budget in alignment with departmental and corporate goals Performs Management Reviews and advise management of any product or process related issues and makes recommendations for improvements. Plans and manages internal audit activities and coordinates audit corrective actions Manages the quality group to ensure effective development and implementation of the Quality System Processes Performs other duties as assigned EDUCATION REQUIREMENTS: Requires BS in a scientific or engineering discipline. EXPERIENCE REQUIREMENTS: Minimum of 10 years of Quality Assurance experience in the medical device industry. Minimum of 5 years of supervisory experience. OTHER QUALIFICATIONS: Requires written and verbal communication and interpersonal skills. Ability to communicate and interact with individuals at all levels of responsibility. This position is based in South San Francisco, CA. The expected salary range for this position is $190,000 - $225,000 , plus comprehensive benefits and equity. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Powered by JazzHR gIh0KwBgJP
    $190k-225k yearly 21d ago

Learn more about quality assurance manager jobs

How much does a quality assurance manager earn in Santa Cruz, CA?

The average quality assurance manager in Santa Cruz, CA earns between $87,000 and $209,000 annually. This compares to the national average quality assurance manager range of $70,000 to $140,000.

Average quality assurance manager salary in Santa Cruz, CA

$135,000
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