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Supplier Quality Manager (Medical Device)

L7

sciproBakersfield, CA6 days ago

Occupations

Quality Control Systems ManagersSupply Chain ManagersRegulatory Affairs Managers

Industries

Surgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingElectromedical and Electrotherapeutic Apparatus Manufacturing
Supplier Quality Manager
On-site: 3 days per week (Grand Rapids / Caledonia, MI)
Compensation: Up to $140K base, 10-12% annual bonus, possible sign-on bonus, health insurance, 401(k)
Reports to: Senior Director of Quality
Travel: Up to 25% (domestic and international supplier visits and audits)
Sponsorship: unavailable, no C2CThe RoleThis is an exciting managerial position with a VC-backed medtech company that has tripled in size in the last 5 years, spanning reusable and disposable surgical products and aiming to add $200M in revenue over the next 2 years. In this role, you’ll own supplier quality across global operations, including finished goods supplier quality at the Caledonia distribution center. You’ll start with a team of one direct report, hire a second right away, and grow the team by 1-2 more people over the next 6-12 months.
What You’ll Do:
  • 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.
Nice to Have: M&A due diligence or integration experience (a bonus)CQE, CQA, Six Sigma, or Lean certificationERP/QMS software familiarity International supplier experience (Mexico, Asia, Europe) and EU MDR knowledge
Apply now (opens in a new tab)
Apply now (opens in a new tab)

Level

ManagerL7

Location

Bakersfield, CA

Occupation

Quality Control Systems Managers

Industry

Surgical and Medical Instrument Manufacturing

Posted

6 days ago

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