Quality Auditor - Medical Device

SQA Services • Austin, TX

1d • Onsite

About The Position

SQA Services, a leading provider of managed supplier quality services for nearly 30 years, offers audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across various industries. They utilize a global network of highly skilled associates to provide rapid on-site support at supplier locations. SQA is seeking a Medical Device Supplier Quality Auditor for a contract opportunity. This role involves performing supplier quality audits at various suppliers in Texas and surrounding states. Audits typically last 1-2 days, and auditors have the flexibility to accept or decline assignments based on their availability.

Requirements

• 5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
• Has been the lead auditor in at least 10 audits
• Direct audit experience to ISO 13485, 21 CFR part 820, and ISO 23908
• Strong communication and writing skills
• Proven ability to deescalate workplace conflicts effectively
• Ability to adapt to new technology and software
• Willingness to travel regionally

Nice To Haves

• Direct audit experience to ISO 17025, 21 CFR part 58, IPEC, ICH Q7, and/or 21 CFR part 210/211
• ISO certifications are a plus but not mandatory

Responsibilities

• Perform supplier audits at various sites within your region of residence
• Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries
• Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
• Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc…
• Respond to the Content team in a timely manner regarding edits/questions to your audit report
• Write audit reports in accordance with client specifications

What This Job Offers

• Career Level: Senior
• Education Level: No Education Listed
• Number of Employees: 101-250 employees