QA Lead Specialist

About the Position

This is an on‑site Quality Assurance role located in Madison, WI. You will report to the Quality Manager and serve as a peer leader and subject‑matter expert. Key responsibilities include leading deviation and CAPA activities and overseeing the review and release of final products.

• Lead, mentor, and train Quality Assurance staff, serving as the subject‑matter expert.
• Lead quality events and CAPAs, drive root‑cause analysis, and contribute to continuous improvement initiatives.
• Author, maintain, and continuously improve SOPs, Quality Systems, and Quality Assurance procedures.
• 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).

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

• Experience with Master Control eQMS and Dynamics 365 ERP software.
• Background in Continuous Improvement and/or Lean Manufacturing.

This position is eligible for bonus/incentive pay. The benefits package includes paid time off, medical, dental, and vision insurance, and a 401(k) plan available to eligible employees.

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.