Danaher Corporation Supervisor Quality Assurance in Lodi, California
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Supervisor, Quality Assurance leads the team responsible for the maintenance of Quality System documentation as related to Device History Record (DHR) compliance and ensuring accuracy and traceability of data and in accordance with the requirements of FDA's Quality System Regulation (QSR) and ISO 13485(ISO). The role has responsibility for the team to conduct timely and effective GMP review and release of product and documentation.
This position is part of the Quality Assurance Team and will be located in Lodi, California
In this role, you will have the opportunity to:
Prioritize the daily QA team activities to ensure DHR review and product release service levels are met.
Train and supervise QA personnel to support QA review and release activities.
Provide guidance on completeness and compliance with QSR and ISO requirements; ensure good documentation practices are followed. Address deficiencies and ensure completion of follow-up actions, specifically those that target process fixes to maintain consistent resolution to all batch review issues.
Generate or update written standard operating procedures to define and improve Quality System functions.
Develop and maintain QA metrics to track batch record and document review capabilities and workflow. Maintain and report out Daily Management KPI and release metrics.
The essential requirements of the job include:
Bachelor’s degree in scientific, quality system, or related discipline, with minimum 8 years of quality related experience in a regulated manufacturing environment or
Master’s degree in scientific, quality system, or related discipline, with minimum 4 years of quality related experience in a regulated manufacturing environment.
Medical Device experience
It would be a plus if you also possess previous experience in:
Experience with Nucleic Acid Testing In-vitro Diagnostic products
Extensive knowledge of QSR and ISO 13485 requirements
Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid