DSM

1 day ago

Senior Supplier Quality Engineer - Exton, PA

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Last checked: 7 hours agoStatus: Live

Job Summary

Own supplier quality engineering for the biomedical group, supporting stability and predictability of the supply chain. Serve as the primary quality contact for vendors, manage supplier qualification and the Approved Supplier List, and develop QA procedures. Lead root-cause analysis, process mapping, impact assessments, and CAPA/KPI reviews, and perform CMO/supplier audits with downstream action tracking. Ensure compliance with ISO 13485 and 21 CFR Part 820 while partnering across internal teams.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Support the biomedical group by qualifying and maintaining suppliers for all product lines to improve stability and predictability of the supply chain.
•Own and manage the supplier qualification process and the Approved Supplier List, including developing QA procedures.
•Perform supplier/CMO root cause analysis, process mapping, and impact assessments for change control, and lead corrective actions.
•Lead external audits of CMOs/suppliers, report findings, and track required actions.
•Lead focused, multidisciplinary teams, mentor supplier quality team members, and ensure compliance with quality system procedures and regulations (ISO 13485, 21 CFR part 820).

Pay and Benefits

Salary: USD 115,000

Perks:Health InsurancePaid Leave

Key Requirements

•BS degree in an engineering discipline (Biomedical, Mechanical, Materials, etc.) or Materials Science, or equivalent undergraduate experience.
•8-12 years of Quality Engineering or Supplier Management in an FDA-regulated medical device, pharmaceutical, biotech, or other regulated industry.
•Lead auditor ISO 13485 certification (practicing for a minimum of 5 years).
•Experience with 21 CFR 820.
•Hands-on supplier and component qualification experience, plus experience with statistical analysis and quality systems (GMP).

Experience:8-12 yearsFDA-regulatedMedical devicePharmaceuticalBiotechRegulated industry

Education:Bachelor's in Engineering or Materials Science

Skills:CommunicationTeamworkLeadershipMentorshipMultitasking

Certifications:ISO 13485Six SigmaASQ QECQA

Tech Stack:MS OfficeWordExcelOutlookMinitabSPCCAPAKPI

Company Brief

DSM

DSM-Firmenich is a global leader in food ingredients, nutrition, fragrances and beauty solutions, formed by the merger of DSM and Firmenich to provide sustainable, science-driven products and services across food, health and personal care industries.

Industry: Chemical Manufacturing

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Headquarters: Geneva, Switzerland

Founded: 2023

Website LinkedIn

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DSM