QA Lead Specialist

Danaher Corporation • Madison, WI

2d • Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Aldevron, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time. Learn about the Danaher Business System which makes everything possible. This position is part of the Quality Assurance department located in Madison, WI and will be an on-site position. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. As a member of the Quality Assurance team, you will report to the Quality Manager and serve as a peer leader and Subject Matter Expert. In this role, you will lead deviation and CAPA activities, and oversee the review and release of final products. In this role, you will have the opportunity to: Lead, mentor, and train Quality Assurance staff, serving as the subject matter expert Lead quality events and CAPAs, drive to root cause, and contribute to continuous improvement initiatives Author, maintain, and continuously improve SOPs Quality Systems and Quality Assurance Create the working schedule for Quality Assurance staff, review and monitor daily work, and track weekly performance metrics Provide front-room support during audits (ISO 13485, internal, and client audits)

Requirements

• 6 years experience in an ISO 13485 and/or GxP environment
• 3 years experience with root cause analysis and/or technical writing
• Bachelor of Science in Biology, Biochemistry, or related field required

Nice To Haves

• MasterControl eQMS and Dynamics 365 ERP software
• Background in Continuous Improvement and/or Lean Manufacturing

Responsibilities

• Lead, mentor, and train Quality Assurance staff, serving as the subject matter expert
• Lead quality events and CAPAs, drive to root cause, and contribute to continuous improvement initiatives
• Author, maintain, and continuously improve SOPs Quality Systems and Quality Assurance
• Create the working schedule for Quality Assurance staff, review and monitor daily work, and track weekly performance metrics
• Provide front-room support during audits (ISO 13485, internal, and client audits)

Benefits

• Aldevron, a Danaher operating 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.
• This job is also eligible for bonus/incentive pay.
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees