Supplier Quality Manager (Medical Device)
Supplier Quality Manager (Medical Device)
Posted today
SENIORITY
Manager
About the role
- Qualify and onboard suppliers under FDA QMSR and ISO 13485, and maintain the Approved Supplier List.
- Manage supplier performance: set KPIs, build scorecards, run reviews, and drive SCARs to timely, effective closure.
- Run a risk-based audit program (on-site and remote, domestic and international) against ISO 13485 and 21 CFR Part 820, and support regulatory inspections.
- Oversee incoming inspection and nonconforming material, including sampling plans, specifications, and holding suppliers accountable.
- Handle supplier change notifications and support NPD programs so suppliers are ready at launch.
- Support M&A by assessing acquisition targets’ supplier quality programs, consolidating ASLs, and rationalizing the supplier base.
- Drive continuous improvement by harmonizing procedures and supplier quality agreements and building supplier relationships.
- What You Bring
- Bachelor’s in Engineering, Life Sciences, Quality, or a related field 7+ years of quality experience in medical device, with 3-5+ years in supplier quality
- Working knowledge of QMSR, ISO 13485, and ISO 9001 Hands-on experience with supplier audits, SCARs, and ASL/qualification programs
- Command of FMEA, root cause analysis, CAPA, control plans, and statistical sampling
- Strong communication skills, including presenting data to leadership
- Direct leadership experience or the ability to lead through influence
- Open on level: The client will consider strong individual contributors (Lead, Senior, or Staff Supplier Quality Engineers) ready to step into management.
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
