Lead Auditor
Bio-Rad Laboratoriesabout 1 year ago
Seattle, Washington, United States
On-site
Full-time
Junior Level (1-3 years)
Job Description
Key Responsibilities
- Help to create and foster a quality environment and mindset throughout the business by coordinating the Internal, External and Customer Audits including regular meetings to prepare, follow up on action items and escalate as needed.
- Maintain the consistency of high quality standards across Bio-Rad by aligning local and regional procedures with our global processes.
- Drive change and transform the way we tackle challenge with support for additional quality and compliance activities, including update to inter-divisional company agreements.
- Coordinate planning, approval, and execution of the annual internal Seattle Operations audit schedule and program.
- Document management: Maintains and stores current quality certificates, Memorandum of Understanding, contracts with auditing organizations, audit reports, Design History Files, and other records as assigned.
Required Qualifications
- Bachelor's degree or equivalent in Biology, Chemistry, Medical Technology, or related field.
- Qualified Lead Auditor with Lead Auditor training.
- Certification with a recognized accreditation body preferred (ASQ certification highly desired).
- 5 years experience in regulated industry or equivalent combination of education and experience.
- Experience working in the area of quality management systems and/or regulatory affairs strongly preferred.
- Working knowledge of global governing regulations, requirements, and standards such as 21 CFR Parts 803, 806, 820, 11, ISO 13485, ISO 14971, European IVD Regulation, and the Medical Device Single Audit Program / participating country regulations.
Preferred Qualifications
- Experience with AI (Artificial Intelligence) is preferred.
Benefits & Perks
- Competitive medical plans for you and your family.
- Free HSA funds.
- New fertility offering with stipend.
- Group life and disability.
- Paid parental leave.
- 401k plus profit sharing.
- Employee stock purchase program.
- A new upgraded and streamlined mental health platform.
- Extensive learning and development opportunities.
- Education benefits.
- Student debt relief program.
- Pet insurance.
- Wellness challenges and support.
- Paid time off.
- Employee Resource Groups (ERG's).
Required Skills
Audit Planning
Risk Management
ISO 14971
Documentation Management
Regulatory Compliance
External Auditing
ISO 13485
Quality Management Systems
Internal Auditing