Overview
Supplier Quality Associate (Medical Device) Jobs in Massachusetts, United States at United Pharma
Title: Supplier Quality Associate (Medical Device)
Company: United Pharma
Location: Massachusetts, United States
Supplier Quality Associate (Medical Device)
Location: MA
Key Responsibilities
- Support supplier qualification, evaluation, and onboarding activities.
- Maintain supplier quality documentation and records in accordance with Quality Management System (QMS) requirements.
- Assist with Approved Supplier List (ASL) administration and maintenance.
- Coordinate and support Supplier Corrective Action Requests (SCARs), including investigation, follow-up, and timely closure.
- Monitor supplier performance using scorecards, metrics, and key performance indicators.
- Investigate supplier-related nonconformances and support disposition activities.
- Participate in root cause investigations and implementation of corrective and preventive actions (CAPA).
- Review supplier documentation to ensure compliance with internal procedures and applicable regulatory requirements.
- Assist with supplier audits, audit responses, and follow-up actions.
- Collaborate cross-functionally with Engineering, Manufacturing, Purchasing, and Quality teams to resolve supplier quality issues.
- Support supplier remediation initiatives and continuous improvement projects to strengthen supplier quality controls.
Required Qualification
- sBachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline
- .3–8 years of experience in supplier quality or quality assurance within the medical device, pharmaceutical, or other highly regulated manufacturing industries
- .Hands-on experience with
- :Supplier Quality Managemen
- tSupplier Control
- sSupplier Corrective Action Requests (SCARs
- )Corrective and Preventive Actions (CAPA
- )Nonconformance Managemen
- tRoot Cause Analysis and Problem Solvin
- gWorking knowledge of
- :FDA 21 CFR Part 82
- 0ISO 1348
- 5Strong technical documentation, report writing, and communication skills
.Preferred Qualification
- sExperience conducting or supporting supplier audits
- .Knowledge of Approved Supplier List (ASL) management and supplier performance scorecards
- .Familiarity with PFMEA, risk management, or supplier risk assessments
- .Experience using quality and enterprise systems such as TrackWise, Windchill, Agile PLM, SAP, ETQ, or similar QMS/ERP platforms
- .Certification in Quality (e.g., ASQ Certified Quality Engineer or Certified Quality Auditor) is a plus
.
