Supplier Quality Engineer – Medical Devices (Onsite Boston)

Barrington James; Boston (MA); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Barrington James is seeking a highly skilled Supplier Quality Engineer for an onsite role in Boston, MA. You will lead supplier qualification, audits, and performance management within a fast-paced MedTech environment developing glaucoma and corneal therapies.

The ideal candidate has 5+ years in supplier quality, strong knowledge of FDA regulations and ISO 13485, and proven ability to drive CAPAs, investigations, and supplier scorecards across cross-functional teams.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years in supplier quality or quality engineering.
• Experience with medical device manufacturing and supplier controls.
• Knowledge of FDA regulations, ISO 13485, ISO 14971.
• ASQ/CQE/CQA certifications preferred.

Responsabilités

• Lead supplier qualification, assessment, and performance management activities.
• Conduct supplier audits, assessments, and on-site inspections to ensure compliance with regulatory and company requirements.
• Drive supplier related non-conforming material investigations, supplier corrective actions to resolve product quality issues.
• Drive execution of existing agreements, perform supplier quality audits and maintain supplier quality documentation.
• Monitor supplier related metrics, scorecards and performance.
• Support QMS improvements and First Article Inspection process.

Connaissances

Supplier quality

Auditing

Root cause analysis

Quality systems

Formation

Bachelor's degree in Engineering

Outils

QMS

Description du poste

Barrington James is seeking a highly skilled Supplier Quality Engineer for an onsite role in Boston, MA. You will lead supplier qualification, audits, and performance management within a fast-paced MedTech environment developing glaucoma and corneal therapies.

The ideal candidate has 5+ years in supplier quality, strong knowledge of FDA regulations and ISO 13485, and proven ability to drive CAPAs, investigations, and supplier scorecards across cross-functional teams.