sciproEast Boston, MA
Supplier Quality Manager (Medical Device)
Supplier Quality Manager (Medical Device)
Supplier Quality Manager (Medical Device)
sciproEast Boston, MA
4 days ago
Surgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingElectromedical and Electrotherapeutic Apparatus Manufacturing
Apply for this role (opens in a new tab)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
Also on the board Same function, level within a rung
Level
Manager
Location
East Boston, MA
Occupation
Quality Control Systems Managers
Industry
Surgical and Medical Instrument Manufacturing
Posted
4 days ago