Lead Auditor

Bio-Rad Laboratories • Seattle, WA

294d • $100,800 - $138,600

About The Position

Support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Lead Auditor/Audit Coordinator. As part of Bio-Rad's Seattle Operations Regulatory Affairs team, you'll apply your strong leadership skills and knowledge of regulatory requirements to ensure that our QMS and the products we distribute are in compliance to local and international regulations and applicable standards, escalate issues as necessary, complete necessary documentation and optimize our processes and procedures. You'll also work closely with Seattle Operations Regulatory Affairs team and cross functional teams to ensure all the non-conformances are resolved and corrective actions are documented as needed.

Requirements

• 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.

Nice To Haves

• Experience with AI (Artificial Intelligence) is preferred.

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.

Benefits

• Competitive medical plans for you and your family.
• Free HSA funds.
• A 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree