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. 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.

About the role

• Lead quality events and CAPAs
• Drive to root cause
• Contribute to continuous improvement initiatives
• Author, maintain, and continuously improve SOPs
• Create the working schedule for Quality Assurance staff
• Review and monitor daily work
• Track weekly performance metrics
• Provide front-room support during audits (ISO 13485, internal, and client audits)

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

Qualifications

• Experience in a similar role
• Strong communication and leadership skills
• Ability to work independently and as part of a team
• Attention to detail and strong organizational skills

Skills

• Quality assurance experience
• Technical writing skills
• Root cause analysis
• Continuous improvement
• Lean manufacturing

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.

Pay

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. 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.

Schedule

The position is an on-site position located in Madison, WI.