Strategic Supplier Quality Engineer (ISO 13485)

Millstone Medical

Fall River (MA)

On-site

USD 90,000 - 110,000

Full time

14 days+

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Benefits offered by this job

Medical

Dental

Vision

Life

Disability

Tuition Reimbursement

Career Pathing

401(k) with match

Job summary

Millstone Medical Outsourcing is seeking a Supplier Quality Engineer to support Tier 1 supplier projects and manage supplier quality programs. You will lead supplier assessments, audits, and CAPA-related activities to ensure compliance and quality across materials and processes.

Ideal candidates bring 5-7 years in ISO 13485 environments, strong problem-solving skills, and the ability to collaborate across teams.

Qualifications

Experience in ISO 13485 environment is required.
Experience with packaging materials and processing is highly desirable.
Ability to work in a team environment.
Able to multitask and work independently.
Excellent problem solving and decision-making skills.

Responsibilities

Perform supplier assessments including performance reviews, onsite audits, and quality agreement reviews.
Lead supplier corrective action teams across multiple sites as part of the CAPA system.
Lead change control efforts relating to supplier changes through the change control process.
Manage supplier assessment schedule and PPAP/Plan development for Tier 1 suppliers.
Monitor nonconforming materials and ensure timely disposition with internal/external teams.
Provide internal and client-facing metrics and supplier performance reviews.
Participate in internal and external audits as needed.