About this role
About the Role Join Aldevron's Quality Assurance team in Madison, WI as a Quality Assurance Lead. You will report to the Quality Manager, serve as a subject matter expert, lead deviation and CAPA activities, and oversee the review and release of final products in an ISO 13485/GxP environment. What You'll Do
- 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 and Quality Systems
- 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) What We're Looking For
- 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 Nice to Have
- MasterControl eQMS and Dynamics 365 ERP software
- Background in Continuous Improvement and/or Lean Manufacturing Compensation & Benefits Aldevron offers comprehensive benefits including paid time off, medical/dental/vision insurance and 401(k). This job is also eligible for bonus/incentive pay.