Quality Assurance Audit Lead

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role

 

As Quality Specialist Lead Auditor, you will be the lead for our site’s audit program. You will serve as the "face of quality" during customer, regulatory (FDA, ISO, etc.), and internal audits. Beyond the audit room, you will act as a subject matter expert (SME), providing guidance on Quality Management System (QMS) inquiries and ensuring our manufacturing processes remain in a state of continuous compliance. 

 

• Lead and manage the end-to-end audit process, including preparation, hosting (front-room/back-room management), and post-audit reporting.
• Ensure the site remains compliant with relevant standards (e.g., ISO 9001, ISO 13485, MDSAP, EXCiPACT,  21 CFR Part 820) and serve as the primary liaison with regulatory bodies.
• Develop and execute the annual internal audit schedule to identify risks and drive process improvements.
• Oversee the lifecycle of audit findings, ensuring robust root cause analysis and timely implementation of Corrective and Preventive Actions.
• Provide daily guidance to cross-functional teams (Operations, Engineering, Supply Chain) regarding QMS requirements and documentation standards.
• Maintain and report on Quality Performance Indicators (KPIs) related to audit readiness and compliance health.

 

Who You Are

 

Minimum Qualifications:

 

• Bachelor's degree in Biology, Chemistry, Biochemistry or other Life Science discipline.
• 2+ years of Quality experience in a regulated manufacturing environment.

 

 

Preferred Qualifications:

 

• Certified Quality Auditor (CQA) or lead Auditor certification (ISO).
• Proven track record of leading successful FDA or Notified body inspections.
• Deep understanding of Root Cause Analysis (RCA) tools (5 Whys, Fishbone).
• Excellent communication, interpersonal, and collaboration skills.
• Detail-oriented, organized, and able to manage multiple audits simultaneously.
• Problem-solving and analytical skills.

 

RSREMD

 

• Pay Range for this position: $66,800.00- $110,300.00.
• The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

 

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!