Auditor

• 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry


• Extensive experience leading supplier/vendor audits from planning through final reporting


• Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems (QMS)


• Strong experience with CAPA investigations, supplier quality programs, and Regulatory Affairs collaboration


• Manufacturing floor experience with the ability to assess production quality and supplier compliance


• Valid passport and ability to travel 50 60%, including occasional domestic and international travel

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually as applicable.