Quality assurance manager jobs in Berkeley, 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).

Job Requirements Qualifications: Strong experience in automation testing using Playwright and Typescript (automation first mindset) Experience working as a Quality Assurance Engineer 3+ years' experience in manual testing Strong experience in API and Backend testing of cloud technologies Experience with API contract validation, versioning Experience working with SQL/NoSQL systems UI automation Strong coding experience with automated testing frameworks, tools and services Preferred Qualifications: Fluency in programmatic-level testing, user-level automation, and API level testing Experienced in Agile or Scrum software development methodologies Supply chain experience is plus Role details As a Quality Assurance Engineer, you will play a key role in setting up the testing strategy and tools for testing cloud software systems and features from the ground up. You will test a wide range of cloud technologies both in isolation and within the larger product ecosystem. The successful candidate for this role will be obsessed with finding and categorizing bugs, ensuring feature completeness and assessing reliability and performance of cloud systems. Proven experience as a Software Automation Engineer (2-3+ years) with strong hands-on skills in Playwright/TypeScript. An eye towards automation to perform repetitive testing tasks as well as regression testing covering various versions of end user client software. Provide coding and testing expertise for our team and be a constant advocate for our customers. High level of coding aptitude combined with a demonstrated passion for Quality Assurance and be responsible to own and drive complex projects. Test Automation Frameworks: Design and implement robust Test Automation Frameworks to ensure reusability, maintainability, and scalability of automation scripts. Continuous Improvement: Stay up to date with emerging technologies and best practices in test automation and continuously optimize the test automation process. Strong coding skills in TypeScript/React/Nest and Python/Java Proven experience in UI, API, and backend integration tests

Job Posting Start Date 12-01-2025 Job Posting End Date 02-01-2026Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.Job Summary To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Quality Manager located in Milpitas, CA. Reporting to the Director, Engineering Services, the Quality Manager, will be responsible of develop, implement, and coordinate product assurance program to prevent or eliminate defects in new or existing products. What a typical day looks like: Researches, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team. Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities. Contributes with other top management personnel in formulating and establishing company policies, operating procedures and goals. Develops initial and subsequent modifications of product assurance program to delineate areas of control, personnel requirements and operational procedures within program. Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program. Conducts management meetings with product assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish controls and procedures for attaining goals. Interface with customers on technical/quality issues and improvement initiatives. In charge of managing customer audits and regulatory/compliance agency audits. Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures. Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders and vendor quality standards. Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems. Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry. The experience we're looking to add to our team: Bachelor's degree 10+ years of experience in a similar position Knowledge of the MS Office (Excel, Word) Contract Manufacturing experience ASQC ISO standards 9001 QMS - Quality Management system Experienced in corrective and preventive actions (CAPA) and writing validation reports (IQ/OQ/PQ). Solid knowledge of GD&T, PFMEA and Control Plans. Ability to interface and communicate with different levels of the organization Strong communication skills and collaboration Supervisor experience Here are a few of our preferred experiences: Experience using Statistics, Lean and Six Sigma Methodologies along with Measurement System Analysis, SPC, DOEs, Reliability desirable. Aerospace or military background with quality standards PF38 #LI-PF1 What you'll receive for the great work you provide: Full range of medical, dental, and vision plans Life Insurance Short-term and Long-term Disability Matching 401(k) Contributions Vacation and Paid Sick Time Tuition Reimbursement Pay Range (Applicable to California)$155,600.00 USD - $214,000.00 USD AnnualJob CategoryQuality Is Sponsorship Available? NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).

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 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

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

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.

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

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.

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.

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!

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

ABOUT US AT KINDER'S: What's it like to work at Kinder's? Well, there's a lot of snacking and geeking out over what we all cooked over the weekend. But beyond that, there's also plenty of hard work. Because we don't just like flavor, we're obsessed with it. With over 100 products sold nationwide, we're now a top-five brand in multiple flavor categories at Costco, Walmart, Whole Foods, and more. But we're not your typical CPG company. Privately held and founder-led, we like to think of ourselves as a pirate ship in a sea of cruise ships. Our crew is adventurous and fearless. We chart our own course and chase big ideas to make food unforgettable. As we expand globally and approach $1 billion in revenue, we need other smart-and-scrappy, flavor-obsessed people to come aboard. If you're looking for a place where you can see the real impact of your work, this is it. Every day, you'll be part of a journey to add flavor to millions of meals and lives. How you'll have an impact at Kinder's: The Co-Manufacturing Quality Manager will be responsible for quality assurance at our co-pack partners for our high-growth flavor brand and will play a critical role in both defining and driving compliance with our high quality standards across our co-pack network. You will partner with Kinder's Co-Pack/Operations, Corporate Quality, and Product Development teams, to build an organization and processes that ensure Kinder's delivers high quality and amazing tasting products consistently while adhering to industry best practices for food safety and quality assurance. What are the Key Responsibilities of this Role: Quality Assurance Strategy and Execution - 35% Quality / Food Safety Procedures Work with internal and external teams to drive clear understanding of quality standards and establish robust capability to drive compliance with the goal of consistent quality attainment. Develop / implement continuous improvement program with collaboration with manufacturing partners to ensure consistent elevation of quality standards. Testing Program Evaluate / refine existing company testing procedures and work with internal stakeholders and manufacturing partners to develop robust, balanced program to ensure compliance with key standards. Process Development Collaborate with PD and manufacturing partners to evaluate process development opportunities to drive consistency in lot-level quality attainment. Consumer Quality Support Track / maintain database of consumer complaints or other quality issues. Identify trends in consumer issues and, where applicable, develop corrective action plans for vendor partners or work with internal PD team to develop reformulation strategies. Co-Manufacturing Management; Audit / Compliance - 35% Refine company audit process / manuals and develop clear, effective communication strategy with key manufacturing partners. Collaborate with operations / PD teams to evaluate new manufacturing partners and, where applicable, develop remediation / process improvement programs to ensure compliance with company standards. Maintain audit / regulatory / and SOP tracking systems for manufacturing partners to ensure all documentation is current and compliant with company and / or regulatory standards. Oversee testing at co-packers to ensure products are free of defects and in compliance with quality standards. Participate in investigations, identify quality issues, and create Corrective and Preventative Actions (CAPAs). Develop annual / quarterly vendor business reviews to highlight quality trends and key areas for improvement. Regulatory / Documentation - 15% Monitor FDA /USDA regulatory activities and plant compliance with regulatory standards and act as a liaison for all manufacturing locations, ensuring regulatory compliance within the business unit. Work with PD to catalog robust item specifications and ensure that manufacturing partners are delivering consistent compliance with established standards. Cross-Functional Partnership - 15% Lead cross-functional team to ensure quality standards while also achieving aggressive commercialization timelines. Drive clear cross-functional understanding of key quality issues / drivers and help team make intentional, active trade-offs to balance quality, brand, and commercial objectives. Identify any sources of food safety risk and drive clear organizational understanding and alignment on how to achieve “zero-tolerance” standard. Identify key sources of business risk from quality issues (e.g. variance in appearance, flavor profile, packaging look / feel) and highlight trade-offs to senior management. What You Bring to the Table Education / Experience B.S. in Food Science or related field preferred; A.S required. PCQI & HACCP required, Better Process Control School (Acidified Food School) preferred. 7+ years relevant work experience in FS/QA/QC in CPG Food and Beverage industry. Advanced level food safety technical knowledge, including demonstrated knowledge of microbiology, allergens, FSMA and other food regulations. Experience in innovation and/or product development is a plus. Experience with food audit procedures and systems (e.g. BRC, SQF, Tracegains) strongly preferred. Track record in agile creative thinking, generation of standards / processes, and working with internal and external partners. Collaborative business partner with a track record of helping internal and external stakeholders identify win-win solutions and driving alignment around best course of action and accountability for delivering committed outcomes. Proven strategic thinker excited by a dynamic, highly innovation-focused model. Strong analytical & quantitative acumen with ability to collect and use data to drive better, faster decision-making. Strong project management skills and understanding of new product development process from ideation to execution. Personal Characteristics Business builder who owns and drives results. Growth mindset with an excitement to learn (and teach). Thrive in a dynamic, lean, and agile environment with proven record of completing projects on time in full through excellent cross functional team management, leadership, communication and influence. Self-starter who takes initiative and speaks their mind. Excited to be part of a fast-moving team with the ability to be a leader and a follower. Enjoy making decisions and finding ways to say ‘yes' as often as possible to impactful and important priorities. Things About the Way We Work No two days here are the same. We try to be good team members and good communicators, but we don't live by hierarchy and structure - everyone is a difference maker here. We make a lot of decisions in the face of incomplete information - our team embraces ambiguity and tries to make good decisions fast rather than great decisions slow We believe our job is to take smart risk, not to eliminate risk. We believe in growing our skills and becoming a better company with more managerial expertise, but we are an entrepreneurial company at heart. We aren't trying to be average - we want to do exceptional things and we are willing to work hard to achieve them. Location & Travel The position will be based out of our 20,000 sq. foot office in Walnut Creek, CA. We strongly believe in the power of culture and community and have a hybrid work structure with 4 days in the office on a weekly basis to encourage collaboration and personal connections that will allow us to better serve our customers and consumer and to have more fun. We have 1 flex day per week with employees having the opportunity to choose to be either in the office or to work from home based on what makes most sense for them. Travel approximately 50% to co-manufacturing partners and industry conferences. The expected starting salary range for this role is $120,000- $140,000 per year. We may ultimately pay more or less than the posted range based on the location of the role. The amount a particular employee will earn within the salary range will be based on factors such as relevant education, qualifications, performance and business needs.

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 ********************

Shift: Monday - Friday; 8:00am - 5:00pm PT Hybrid 1: This role requires associates to be in-office 1 day per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. Internal candidates may be considered with a confirmed virtual exception on file. Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law The Clinical Quality Program Manager is responsible for serving as a liaison with and overseeing the quality improvement activities/projects/programs for one or more states within a major line of business. How you will make an impact: Leads state change to health plan level quality strategy meetings, develops a quality plan, and ensures integration of quality into the overall business process. Works with the clinical intervention team to design studies to identify barriers to medical interventions. Ensures that study methodology is sound and appropriate reporting is in place. Develops performance improvement plans and oversees the clinical quality improvement activities/projects to improve the quality of care for members. Assures compliance with corporate QI work plans. Assures that all QI activities are relevant to the needs of targeted population. Maintains effective documentation of research programs to meet regulatory and Accreditation Standards. Provides oversight to assure accurate and complete quantitative analysis of clinical data and presentation of data analysis results. Participates in and provides input to the development of new product designs for major line of business. Oversees the implementation of new initiatives. Leads interactions with regulators or oversight entities. Oversees quality improvement activities for the largest, most complex state programs. Minimum Requirements: Requires a BS in health administration, nursing, or a related clinical field; 4 years of health care quality or data analysis experience; or any combination of education and experience, which would provide an equivalent background. Preferred skills, capabilities, or experiences: Current unrestricted license, certification in applicable field (i.e. CPHQ) and/or a MS in the health field (i.e. Nursing) is preferred. Intermediate Excel and PowerPoint skills Prior experience with HEDIS and NCQA Health Plan Accreditations For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $95,680.00 to $149,760.00 Locations: California In addition to your salary, Elevance Health offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws . * The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Job Level: Non-Management Exempt Workshift: 1st Shift (United States of America) Job Family: QLT > Clinical Quality Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health. Who We Are Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. How We Work At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business. We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process. The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws. Elevance Health is an Equal Employment Opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. Summary The Quality Assurance Coordinator is responsible for ensuring the laboratory's Quality Management System (QMS) complies with ISO/IEC 17025, ISO 9001,10 CFR 50 Appendix B, and 10 CFR 21 standards. This role oversees testing, calibration, and certification activities to meet regulatory, accreditation, and customer requirements. Job Functions * Maintain and improve QMS in compliance with ISO 17025 and ISO 9001 17065. * Ensure document control and proper recordkeeping for policies, procedures, and work instructions. * Serve as primary contact for accreditation bodies and regulatory agencies. * Manage accreditation audits, external assessments, and regulatory inspections. * Plan, execute, and document internal audits to assess compliance and identify risks. * Assist in Investigation of nonconformities, implement corrective actions, and verify effectiveness. * Ensure personnel involved in testing and certification are qualified, trained, and competent. * Maintain training records and competency assessments. * Conduct or coordinate quality system training sessions. * Promote continuous improvement initiatives in test methods, certification processes, and quality practices. * Assists in addressing customer complaints and ensure proper investigation and resolution. * Communicate quality system updates and compliance status to management. * Work with * staff to ensure test and certification results are accurate and reliable. Qualifications Education and Experience * High School diploma or equivalent (Required) * Bachelor's degree in relevant field preferred * 3 + years of experience in a quality role, preferably in a testing or certification environment. * Strong understanding of ISO/IEC 17025, ISO 9001, and 10 CFR 50 Appendix B, 10 CFR 21. * Writing skills for SOPs, audit reports, and compliance documentation. Knowledge, Skills, and Abilities * Critical Thinking & Problem-Solving: Ability to analyze complex quality and compliance issues. * Experienced with quality management software, document control systems, and data analysis tools. * Ability to manage multiple priorities, meet deadlines, and maintain structured documentation. * Strong writing skills for SOPs, audit reports, and compliance documentation. * Attention to Detail: Strong ability to detect nonconformities and inconsistencies. * Ability to work effectively with individuals from varied professional and cultural backgrounds. Physical Demands of the Job * Stand: None * Move or traverse: None * Sit: None * Use hands: None * Reach with hands and arms: None * Climb or balance: None * Stoop, kneel, crouch or crawl: None * Talk/hear: None * Taste/Smell: None * Lift/carry/push or pull: None Additional Information * Pay Range - $25.00 to $28.00 * Benefits - This position offers medical, dental, vision, 401K, time off benefits and participation in the company's Annual Incentive Plan. Additional Information SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

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!