Supplier Quality Engineer

Barrington James; Boston (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Supplier quality

Auditing

Root cause analysis

Quality systems

Education

Bachelor's degree in Engineering

Tools

QMS

Job description

Supplier Quality Engineer - Medical Device - Onsite - Boston, MA

My client is an innovative MedTech developing next-generation therapies for the treatment of glaucoma and corneal disorders. Due to continued growth across the US market, they are seeking an experienced Supplier Quality Engineer to join their collaborative engineering team. This is an exciting opportunity to work on cutting-edge medical devices while partnering cross functionally across manufacturing, mechanical engineering and external suppliers in a fast-paced, solution-oriented environment.

Responsibilities:

• 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.

Qualifications:

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years of experience in Supplier Quality, Quality Engineering, or a related field.
• Experience within medical device manufacturing environments and supplier controls.
• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, with ability to apply for design controls, risk management and process controls.
• Experience conducting supplier audits and managing supplier quality programs.
• Knowledge of QMS, root cause investigations, corrective actions, and supplier performance management.
• ASQ/CQE/CQA certifications are preferred.