QA Lead Specialist

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. 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 part of our team you will help bring life‑changing innovations to life—impacting millions around the world. This position is part of the Quality Assurance department located in Madison, WI and will be an on‑site position. You will report to the Quality Manager and serve as a peer leader and Subject Matter Expert, leading deviation and CAPA activities and overseeing the review and release of final products. 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 for 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) Essential Requirements 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 related field required Preferred Qualifications Experience with MasterControl eQMS and Dynamics 365 ERP software Background in Continuous Improvement and/or Lean Manufacturing Benefits Competitive benefit programs including health care, paid time off, and 401(k) Eligible for bonus/incentive pay Comprehensive package of benefits: paid time off, medical/dental/vision insurance, and 401(k) 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. The U.S. EEO posters are available. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: View phone number on click.appcast.io or View email address on click.appcast.io. #J-18808-Ljbffr