Quality assurance manager jobs in Richmond, CA

Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly respected professionals. Yorke Engineering, LLC has assisted over 1,400 client organizations with their Air Quality and Environmental Compliance, Engineering, and Permitting needs. Our philosophy is to efficiently help government and industrial customers with the complex array of environmental laws and regulations. From simple permits to complex agency negotiations, from small companies to the largest of California's organizations, Yorke successfully solves our clients' Air Quality and Environmental challenges. Our team has over 1,000 years of combined environmental experience and consists of engineers and scientists that specialize in Air Quality, Waste, Water, CEQA, Safety, and Industrial Hygiene. We are looking for a sharp Mid to Senior level Air Quality Engineer/Scientist (Environmental Permitting and Compliance) to join our team in Northern CA. This is a full-time position at 40 hours per week from one of our Northern CA offices (Berkeley, San Francisco, or San Jose) during our normal business hours. We offer competitive salaries, a full benefits package including Paid Time Off, Holidays, Full Medical/Dental/Vision, along with a 401k program with a generous company match. Position Summary: The Mid to Senior level Air Quality Engineer/Scientist (Environmental Permitting and Compliance) performs professional engineering work, leading and executing the compliance and permitting functions in relation to Air Quality Regulations and Compliance. This candidate will be reviewing processes and equipment, analyzing permit-related technical and regulatory issues, and communicating those analyses within Yorke, the client organization, with government agencies and with the public at large. The work is challenging, broad in scope, and variable from project to project. The position involves effective communication, decision-making, and time management. The candidate performs other duties as required or assigned. The candidate's experience and qualifications we are seeking include: 5-15+ years of work experience in the Air Quality and/or Environmental industry in an engineering role (preferably in a consulting environment); Experience in the environmental services industry focusing on Air Quality services: Process and equipment review; Air quality permitting under BAAQMD, SCAQMD, SJVAPCD and other Air Districts, including Title V Permitting; RECLAIM implementation and reporting; Annual Emissions Reporting; Air Dispersion Modeling; Air Quality Assessments including Data Analysis and Emission Inventories; General Air Quality Compliance for facilities in CA. Ability to be an active team member on project teams towards project completion within project scope, budget and schedule and ensure quality work product and deliverables; Ability to work with clients, staff, and regulators through effective communication and expertise by fostering a collaborative environment without losing focus of quality; Proven track record or desire to engage in successful regulatory work in dealing with the SCAQMD, BAAQMD, SJVAPCD, EPA, CARB and/or other similar regulatory agencies; Experience or desire to work on-site at client facilities; Prepare reports and submissions in timely manner; Experience with handling highly technical data and technical data interpretation; Highly motivated to continue working in Air Quality environmental field and expand their knowledge and experience; CA Regulatory/Compliance experience is required. Job Requirements: B.S or M.S. degree in Chemical Engineering, Environmental Engineering, or Mechanical Engineering, or other relevant technical degrees from an accredited college (minimum GPA of 3.0); Ability to work collaboratively in a team fashion, handle several projects at once, prioritize work, and work efficiently; Desire to learn or developing technical expertise in environmental rules and regulations; Excellent oral and written communications skills; Experience in conflict resolution and crisis management; Track record of successful analysis, interpretation, and application of rules and regulations towards practical solutions; Ability to think critically and develop solutions; Software Knowledge: Strong Microsoft Excel, Word, Outlook, and Powerpoint skills (required); Microsoft 365 Applications, including Sharepoint (a plus) EIT, CPP or P.E. Certification (a plus).

The Senior Quality Engineer will work alongside both business and technical team members to ensure the usability and functionality of products, services and systems. This role will contribute to the overall organization by working to create quality standards and testing systems to reflect efficiency, reliability and Performance. Required Skills · Required Basic Knowledge on Java, GIT/GIT hub, SQL and test methodology, User Interface and Services testing Methodologies · Required Agile/Scrum team experience, supporting automation efforts working with Developers, Test case tracking/documentation/Experience working with Jira Tools/Plugins and processes · Preferred - Good knowledge of Jenkins, API Testing, Java Script, REST and SOAP. Additional Experience: · Experience in software quality assurance techniques · Experience in software test automation (functional and/or performance), with advanced scripting expertise. · Experience in testing the following technologies: Microsoft Transaction Server, COM/COM+, .NET, Crystal Reports, Web. Knowledge of QA principles, concepts, systems, industry practices, and standards. · Strong analytical and problem-solving skills · Knowledge and understanding of software development life cycle (SDLC). · Ability to work independently with minimal supervision · Excellent communication skills both written and verbal. · Strong time management and organizational skills.

About GSPANN Headquartered in California, U.S.A., GSPANN provides consulting and IT services to global clients. We help clients transform how they deliver business value by helping them optimize their IT capabilities, practices, and operations with our experience in retail, high-technology, and manufacturing. With five global delivery centers and 1900+ employees, we provide the intimacy of a boutique consultancy with the capabilities of a large IT services firm. Title: Lead WMS Functional Quality Engineer Location: San Ramon, CA (4 days/week) Job Type: Contractual Duration: Long Term 15+ years of total IT Experience and expertise in technical configuration of WMS product, Solution Integration, Quality Assurance, System Testing, PLSQL, SQL Server, and Performance Tuning. Must have Retail/Ecommerce ERP experience like Manhattan/Blue Yonder/Fluent etc.. 10+ years of experience in progressive web and mobile apps technology and Retail Ecommerce domain. Comfort and experience working in an Agile SCRUM and Test-driven environment. Ensure that the WMS is correctly set up, tested, and commissioned within the warehouse operations. Must have Working experience in Retail Domain with Ecommerce platforms, OMS, WMS, Supply chain, inventory. Exposure and understanding to Modern web standards and technology. Coordinate changes and reconfiguration of the WMS effectively to ensure that day-to-day business operations are not adversely affected during the transition. Gather and understand process requirements for effective process management via the WMS. Conduct system testing prior to any process change go-live. Ensure all relevant and required test cases are executed, documented with results, and implemented in a controlled manner. Draft user acceptance testing (UAT) cases and prepare the system for UAT. Conduct UAT as required. Working at GSPANN GSPANN is a diverse, prosperous, and rewarding place to work. We provide competitive benefits, educational assistance, and career growth opportunities to our employees. Every employee is valued for their talent and contribution. Working with us will give you an opportunity to work globally with some of the best brands in the industry. The company does and will take affirmative action to employ and advance in the employment of individuals with disabilities and protected veterans and to treat qualified individuals without discrimination based on their physical or mental disability status. GSPANN is an equal opportunity employer for minorities/females/veterans/disabled.

Key Skills: Full Stack Validation & Hands-On Testing, Automation Scripting and Tool Development, Data Collection & Analysis, DevOps Required Experience: Proven experience with full stack validation, test case development, and test strategy creation. Proven experience running data collection protocols and managing datasets. Strong experience with Python (and ideally Bash) scripting for data processing and automation. Data analysis and statistical interpretation skills. Meticulous attention to detail with excellent written and verbal communication.

Details: We're seeking a Director of Quality and Mission Assurance to lead reliability, safety, and risk management for an advanced space hardware manufacturer. This executive-level position oversees all quality operations and ensures mission success from design through delivery.The ideal candidate brings deep experience in aerospace quality standards, mission assurance leadership, and the ability to build systems that guarantee product reliability under the most demanding conditions.Key Responsibilities Establish and lead the company's Mission Assurance strategy and framework Manage risk identification, mitigation, and mission-critical tracking across programs Oversee Design Assurance and System Safety programs from concept to flight Lead the Failure Review Board (FRB) and ensure thorough root cause analysis Implement and maintain a comprehensive Quality Management System (QMS) Drive AS9100 certification and compliance with space industry standards Lead supplier quality programs, audits, and technical reviews Oversee manufacturing quality processes, MRB management, and non-conformance control Foster a continuous improvement culture using Lean and Six Sigma tools Build, mentor, and scale a high-performing quality and mission assurance team Details: Education & Experience Bachelor's degree in Engineering, Physical Sciences, or a related technical field 10+ years of experience in aerospace, defense, or space system quality and assurance Proven success implementing QMS and leading quality operations in a startup or growth environment In-depth knowledge of AS9100, NASA, and DoD quality and mission assurance standards Preferred Qualifications Master's degree in a technical discipline Certifications: CQE, CMQ/OE, or equivalent NADCAP accreditation experience (special processes) Experience with reliability engineering, risk analysis, and system safety programs Strong customer-facing and cross-functional leadership experience Ability to blend strategic vision with hands-on problem solving Salary - $212,500 - $261,800

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.

We're seeking a Director of Quality and Mission Assurance to lead reliability, safety, and risk management for an advanced space hardware manufacturer. This executive-level position oversees all quality operations and ensures mission success from design through delivery.The ideal candidate brings deep experience in aerospace quality standards, mission assurance leadership, and the ability to build systems that guarantee product reliability under the most demanding conditions.Key Responsibilities Establish and lead the company's Mission Assurance strategy and framework Manage risk identification, mitigation, and mission-critical tracking across programs Oversee Design Assurance and System Safety programs from concept to flight Lead the Failure Review Board (FRB) and ensure thorough root cause analysis Implement and maintain a comprehensive Quality Management System (QMS) Drive AS9100 certification and compliance with space industry standards Lead supplier quality programs, audits, and technical reviews Oversee manufacturing quality processes, MRB management, and non-conformance control Foster a continuous improvement culture using Lean and Six Sigma tools Build, mentor, and scale a high-performing quality and mission assurance team

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.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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

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.

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!

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Quality Control Manager to join our dedicated team at our project site near Vacaville, California. In this role, you will use your technical knowledge and skills to effectively train, supervise, communicate, execute, and manage the IPS Construction Quality Control and Quality Assurance program for ongoing Construction Projects. This is a leadership role responsible for collaborating with the On-Site Construction Management Team to ensure that established project standards are adhered to. Additional Responsibilities * Develop, plan, manage, and administer the implementation of project-specific Construction Quality Control and Quality Assurance (QA/QC) Plans with CM team, contractors, and clients (multiple Quality Control (QC) specialists, Commissioning, and/or jurisdictional inspection and testing personnel/agencies). * These plans will incorporate the principles, policies, procedures, and methodologies necessary to deliver each project fully compliant with the appropriate contract documents. * Train the project team on their criteria and implementation. * Work with the Project Executives and Project Managers to ensure that sufficient, qualified, specialized staff are assigned to provide the required knowledge and experience to execute the plan. * Oversee QA/QC site-related activities: oversee testing, inspection, and acceptance of work; inspect and accept materials and equipment; identify deficiencies and non-conformances and track them through resolution and acceptance; prepare and submit quality control reports; review quality control documentation for specialty items and shop and field operations for subcontracted trades. * Develop special Inspection Test Plans and System Completion records that will be incorporated into the QA/QC Project-specific plans. * Report and publish quality reports, audits, and initiatives to the Project Manager and review with the project team before publication. * Provide risk avoidance techniques and identify quality risks to projects and IPS. * Ensure Corporate Quality initiatives and goals are achieved. * Evaluate testing, sampling methodologies, technologies, and equipment to confirm correct applications are implemented. * Review utility matrices developed to start up and commission systems and skids. * Direct the tracking of deficiencies, test results, or other regularly reported quality control data; manage non-conformance reporting activities and track efficiencies from identification through resolution. * Verify that the construction of systems and equipment is installed in accordance with approved construction documents. * Understand and apply federal, state, and local codes, policies, laws, and regulations * Identify quality problems or areas for improvement and recommend solutions. * Inspect and evaluate the adequacy of work performed by subcontractors. * Assist in performing system walk-downs/final inspections; closeout and startup; establish system completion punch list items; and ensure all deficiencies are corrected. * Conduct and/or attend QC meetings. * Attend pre-construction and construction meetings, noting areas/topics that may present future problems/risks and present to the project manager for consultation. * Assist the project team with the identification of QA/QC hold points that could impact project milestone dates. * Possess a working knowledge of the company safety program, laws, and OSHA operating standards. * Implement the corporate safety culture and principles into the QA/QC programs. * Continually improve strategies and tools to efficiently and effectively document, track, and record compliance with the contract documents. * Stop work if necessary, to resolve non-compliant work or matters that negatively affect safety and Quality. * Contribute to a timely project closeout to include compilation and turnover of all required QA/QC documents. * Complete training modules as assigned. * Read and understand construction documents, process flow diagrams, electrical, instrumentation, and control diagrams. The salary offered for this role is between $117,000 and $180,000, but the actual salary offered is dependent on experience, skill set, and education. Qualifications & Requirements * B.S. in a science, engineering, construction management, or related field (10 years of experience accepted in place of a degree). * Candidates are preferred to have Quality Assurance and Quality Control Management training and experience with 10 years of field experience in construction and/or engineering. * Has a strong knowledge of applicable regulatory guidelines within the construction safety and pharmaceutical industry, along with the ability to interpret complex issues and provide recommended courses of action. * Proficient skill level in Microsoft Office Suite. * Valid state driver's license with acceptable driving record. * Ability to successfully pass drug screening test, 10-panel DOT-approved, and background/security checks for on-site project access. * Ability to sit and/or stand for extended periods of time. * Ability to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. * Ability to work indoors and outdoors, exposed to the elements. * First Aid/CPR training. * Primavera P6 and MS Project knowledge. * Commissioning and System startup experience. Context, Environment, & Safety * This position is expected to be full-time on-site. * You may be assigned to a client for an extended period of time (1-2 years). * OSHA 10 certification (IPS will provide tools) must be maintained during employment. * You will focus on construction field activity and office time will be limited. * You will visit Client sites and will be required to adhere to stated safety rules. * This position is a safety-sensitive position. * The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas Physical Demands * Must be able to stand, sit, and walk for prolonged periods. * Must possess the ability to stoop, kneel, crouch, and crawl as required. * Must be able to lift and move objects weighing up to 25 pounds. * Must be able to climb ladders as necessary. Work Environment * Must be able to work in both indoor and outdoor environments, which may include exposure to varying working conditions. * Must be able to adhere to strict cleanroom gowning protocol. Travel * This position will have 50% travel, or as required by the assigned project. * Position may be assigned to a client site for an extended period. * Overnight travel or staying in the city of the Client's location is possible, depending on the assignment. * Please review the IPS Travel Policy. * Position will visit construction sites and will be required to take site safety training and adhere to site safety rules. * Must have access to reliable transportation. * Must have the ability to travel and commute on a daily or routine basis. Safety * This position is a safety-sensitive position. * The employee is designated for field work and attends activities at the client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. #LI-ML1 Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here! * B.S. in a science, engineering, construction management, or related field (10 years of experience accepted in place of a degree). * Candidates are preferred to have Quality Assurance and Quality Control Management training and experience with 10 years of field experience in construction and/or engineering. * Has a strong knowledge of applicable regulatory guidelines within the construction safety and pharmaceutical industry, along with the ability to interpret complex issues and provide recommended courses of action. * Proficient skill level in Microsoft Office Suite. * Valid state driver's license with acceptable driving record. * Ability to successfully pass drug screening test, 10-panel DOT-approved, and background/security checks for on-site project access. * Ability to sit and/or stand for extended periods of time. * Ability to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. * Ability to work indoors and outdoors, exposed to the elements. * First Aid/CPR training. * Primavera P6 and MS Project knowledge. * Commissioning and System startup experience. Context, Environment, & Safety * This position is expected to be full-time on-site. * You may be assigned to a client for an extended period of time (1-2 years). * OSHA 10 certification (IPS will provide tools) must be maintained during employment. * You will focus on construction field activity and office time will be limited. * You will visit Client sites and will be required to adhere to stated safety rules. * This position is a safety-sensitive position. * The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas Physical Demands * Must be able to stand, sit, and walk for prolonged periods. * Must possess the ability to stoop, kneel, crouch, and crawl as required. * Must be able to lift and move objects weighing up to 25 pounds. * Must be able to climb ladders as necessary. Work Environment * Must be able to work in both indoor and outdoor environments, which may include exposure to varying working conditions. * Must be able to adhere to strict cleanroom gowning protocol. Travel * This position will have 50% travel, or as required by the assigned project. * Position may be assigned to a client site for an extended period. * Overnight travel or staying in the city of the Client's location is possible, depending on the assignment. * Please review the IPS Travel Policy. * Position will visit construction sites and will be required to take site safety training and adhere to site safety rules. * Must have access to reliable transportation. * Must have the ability to travel and commute on a daily or routine basis. Safety * This position is a safety-sensitive position. * The employee is designated for field work and attends activities at the client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Quality Control Manager to join our dedicated team at our project site near Vacaville, California. In this role, you will use your technical knowledge and skills to effectively train, supervise, communicate, execute, and manage the IPS Construction Quality Control and Quality Assurance program for ongoing Construction Projects. This is a leadership role responsible for collaborating with the On-Site Construction Management Team to ensure that established project standards are adhered to. Additional Responsibilities * Develop, plan, manage, and administer the implementation of project-specific Construction Quality Control and Quality Assurance (QA/QC) Plans with CM team, contractors, and clients (multiple Quality Control (QC) specialists, Commissioning, and/or jurisdictional inspection and testing personnel/agencies). * These plans will incorporate the principles, policies, procedures, and methodologies necessary to deliver each project fully compliant with the appropriate contract documents. * Train the project team on their criteria and implementation. * Work with the Project Executives and Project Managers to ensure that sufficient, qualified, specialized staff are assigned to provide the required knowledge and experience to execute the plan. * Oversee QA/QC site-related activities: oversee testing, inspection, and acceptance of work; inspect and accept materials and equipment; identify deficiencies and non-conformances and track them through resolution and acceptance; prepare and submit quality control reports; review quality control documentation for specialty items and shop and field operations for subcontracted trades. * Develop special Inspection Test Plans and System Completion records that will be incorporated into the QA/QC Project-specific plans. * Report and publish quality reports, audits, and initiatives to the Project Manager and review with the project team before publication. * Provide risk avoidance techniques and identify quality risks to projects and IPS. * Ensure Corporate Quality initiatives and goals are achieved. * Evaluate testing, sampling methodologies, technologies, and equipment to confirm correct applications are implemented. * Review utility matrices developed to start up and commission systems and skids. * Direct the tracking of deficiencies, test results, or other regularly reported quality control data; manage non-conformance reporting activities and track efficiencies from identification through resolution. * Verify that the construction of systems and equipment is installed in accordance with approved construction documents. * Understand and apply federal, state, and local codes, policies, laws, and regulations * Identify quality problems or areas for improvement and recommend solutions. * Inspect and evaluate the adequacy of work performed by subcontractors. * Assist in performing system walk-downs/final inspections; closeout and startup; establish system completion punch list items; and ensure all deficiencies are corrected. * Conduct and/or attend QC meetings. * Attend pre-construction and construction meetings, noting areas/topics that may present future problems/risks and present to the project manager for consultation. * Assist the project team with the identification of QA/QC hold points that could impact project milestone dates. * Possess a working knowledge of the company safety program, laws, and OSHA operating standards. * Implement the corporate safety culture and principles into the QA/QC programs. * Continually improve strategies and tools to efficiently and effectively document, track, and record compliance with the contract documents. * Stop work if necessary, to resolve non-compliant work or matters that negatively affect safety and Quality. * Contribute to a timely project closeout to include compilation and turnover of all required QA/QC documents. * Complete training modules as assigned. * Read and understand construction documents, process flow diagrams, electrical, instrumentation, and control diagrams. The salary offered for this role is between $117,000 and $180,000, but the actual salary offered is dependent on experience, skill set, and education.

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!

Waymo is an autonomous driving technology company with the mission to be the world's most trusted driver. Since its start as the Google Self-Driving Car Project in 2009, Waymo has focused on building the Waymo Driver-The World's Most Experienced Driver™-to improve access to mobility while saving thousands of lives now lost to traffic crashes. The Waymo Driver powers Waymo's fully autonomous ride-hail service and can also be applied to a range of vehicle platforms and product use cases. The Waymo Driver has provided over ten million rider-only trips, enabled by its experience autonomously driving over 100 million miles on public roads and tens of billions in simulation across 15+ U.S. states. Waymo Operations exists to deliver the Waymo Driver to the world. We are a global team building and scaling the world's first and leading autonomous fleet and operations platform. From component sourcing to end customer management, we enable and create value for Waymo through scaled and orchestrated deployment of the Waymo Driver. At Waymo, we are dedicated to building a culture that promotes inclusivity and celebration. We value diverse backgrounds, perspectives, and experiences; recognize that inclusive actions lead to equitable outcomes; and support and encourage all team members to share their ideas to help Waymo better serve the communities in which we operate. You will: Develop and maintain standard operating procedures, playbooks, and checklists based on safety, regulatory compliance, and program requirements. Monitor validation practices for adherence to quality standards, conduct audits and analyze feedback. Design and execute a formal change management process for all modifications to validation operations standards and procedures. Assess the impact of proposed changes on operations, safety, and project timelines. Develop clear communication plans and lead training efforts to ensure smooth transitions and universal adoption of new processes. Proactively identify potential risks associated with changes and develop robust mitigation strategies to minimize disruption to operations. Track key metrics related to performance and quality, analyze results, and use data-driven insights to drive continuous improvement. Conduct detailed process mapping of current workflows to identify inefficiencies and drive lean principles, ensuring consistency and repeatability of validation outcomes. Facilitate root cause analysis for process failures, and quality deviations to implement corrective and preventative actions to address underlying issues. You have: 7+ years of experience in program or project management, quality assurance, or process improvement within the automotive, aerospace, or a related high-growth tech company . Proven track record of successfully leading complex organizational change initiatives and implementing formal change control processes. Exceptional analytical and problem-solving skills with a meticulous attention to detail. Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams. Strong understanding of quality management principles, audit processes, and data analysis. Bachelor's degree in Engineering, Operations Management, Business Administration, or a related field. We prefer: Master's degree or relevant certifications (PMP, Lean Six Sigma Black Belt) preferred. In-depth knowledge of Quality Management Systems and process improvement methodologies (e.g., Lean Six Sigma). Experience in developing and implementing training programs, preferably in a technical or operational setting. #LI-Hybrid The expected base salary range for this full-time position across US locations is listed below. Actual starting pay will be based on job-related factors, including exact work location, experience, relevant training and education, and skill level. Your recruiter can share more about the specific salary range for the role location or, if the role can be performed remote, the specific salary range for your preferred location, during the hiring process. Waymo employees are also eligible to participate in Waymo's discretionary annual bonus program, equity incentive plan, and generous Company benefits program, subject to eligibility requirements. Salary Range$152,000-$192,000 USD

Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke - the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association's Innovators' Network and CVS Health Point Solutions Management platform. Visit ****************** for more information. About the Role: As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production. Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes. Responsibilities Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones Create and maintain quality control plans across IQC, IPQC, and OQC processes Define and implement manufacturing process controls, test requirements, and build validation plan Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies Drive corrective and preventive actions and verify long-term effectiveness Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health Monitor yields, reduce defects, and drive continuous improvement across production lines Assess supplier capability and lead onsite production reviews and factory evaluations Define incoming inspection criteria, sampling plans, and supplier quality alignment Maintain detailed build documentation, quality dashboards, and audit reports Qualifications 7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma Proven experience leading root cause analysis and driving corrective actions Experience working with contract manufacturers and suppliers, preferably in Asia Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data Excellent communication skills with the ability to present findings and recommendations Experience supporting NPI builds and high-volume product ramp is preferred Familiarity with reliability testing and environmental qualification is preferred Knowledge of hardware system integration spanning mechanical and electrical components is preferred Experience with DOE, process optimization, or Lean Manufacturing is preferred Mandarin language proficiency is a plus The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits. Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.

Quality Control Manager (QCM) The QCM is responsible for implementing and managing the contractor's Quality Control Program (QCP) to ensure all O&M activities meet or exceed contractual requirements. This dual-hatted position also oversees the safe, efficient, and compliant operation and maintenance of the Central Utility Plant, ensuring uninterrupted delivery of critical utilities to the Medical Treatment Facility and supported facilities. The role focuses on scheduled, unscheduled, and emergency maintenance, regulatory compliance, and safety management. Tasks and Capabilities Required: * Develop, maintain, and execute the QCP in compliance with the PWS. * Conduct regular inspections, tests, and performance evaluations across all O&M functions. * Maintain accurate QC records and coordinate closely with Government QA staff. * Provide remedial training and corrective action when deficiencies are identified. * Ensure all work complies with applicable safety standards, including OSHA, NFPA, and EM 385-1-1. Mandatory Experience and Certifications: * Minimum 2 years' Quality Control experience in construction or facility management. * Minimum 2 years' experience in comparably sized health facilities. * OSHA 30-Hour Certification. * Preferred/Desired Certifications: * ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE). Disclaimer: The responsibilities and qualifications outlined above are intended to describe the general nature and level of work performed by those in this position. They are not an exhaustive list of all duties and skills required. The company reserves the right to modify job duties or assign additional duties as needed. Tentative Start Date: 01/01/2026 [5 Year Contract] Special Qualifications/Requirements: Must be able to successfully pass, as required, a federal, state, or local government's background investigation. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities We maintain a drug-free workplace and perform pre-employment substance abuse testing. The contractor 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. However, 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 contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Job Description last Updated: 08/19/2025

Job DescriptionJob DescriptionQuality Control Manager- Ready Mix - Livermore, 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.