Medical Device QA Auditor

Our client, a leading Pharmaceutical Manufacturer is seeking a Certified ISO 13485 Auditor to lead their auditing activities in South San Fran, CA.

Job Title: Medical Device Senior QA Auditor
Location: South San Francisco and San Jose, CA (Two sites as needed for audit)
Contract:6 month contract
Payrange $65-70/hr on W2

Job Description

• Independently plans/leads/conducts wide range of internal audit, Supports in execution of audit strategy, leads process audits and performs special assessments
• Document audit plans and reports
• Actively supports regulatory inspections and preparing for FDA audits
• Identifies and drives process improvements
• Assess the operations executed at the site and supplier for their adherence to regulatory requirements, Quality Agreement requirements
• Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
• Communicate with and influence internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations.

Qualifications

• Must have Associates degree and at least 6 years of experience
• Medical Device manufacturing/Quality experience
• Demonstrated knowledge in medical device regulations (FDA, ISO, MDSAP, IVDR)
• Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as PDM, Quality Tracking Systems, Documentum platforms

Must Haves

• Certified ISO 13485:2015 Lead Auditor, with auditing experience
• MDSAP auditor trained, with preferred experience obtaining / maintaining MDSAP Certificate
• Self-Starter / Go-Getter - Need someone that is going to develop and own the Audit Program, including internal audit scheduling, leading internal audit teams, following up on internal audit responses, and preparing the site for external audits (inspection readiness

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.