Medical Devices: Supplier Quality Engineer (Contract)

Maclivaro Limited; Marlborough (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Maclivaro Limited is seeking a Supplier Quality Engineer for a 12-month freelance contract in Marlborough, MA or Delaware. This on-site role focuses on supplier quality, CAPA management, root-cause analyses and continuous improvement across the supply chain.

The ideal candidate has a strong medical device background, experience with ISO 13485 and FDA requirements, and can lead investigations while collaborating with Engineering, Manufacturing and Regulatory teams.

Qualifications

• Experience in regulatory medical device environment (ISO 13485, FDA)
• Proven ability to manage supplier quality activities and CAPA processes
• Strong investigator mindset with cross-functional collaboration

Responsibilities

• Oversee supplier quality activities ensuring compliance with medical device standards.
• Manage supplier CAPA, non-conformances, root-cause investigations and effectiveness checks.
• Lead supplier-related quality investigations and timely resolution of issues.
• Support CER-related activities and documentation where applicable to supplier quality.
• Identify and resolve supplier and supply chain quality issues impacting product quality or regulatory compliance.
• Conduct supplier audits, assessments and ongoing performance monitoring.
• Collaborate with Engineering, Manufacturing, Procurement, Quality and Regulatory Affairs to implement solutions.
• Support supplier change control, risk assessments and quality agreements.
• Monitor supplier performance and drive continuous improvement across the supply chain.
• Ensure quality documentation, traceability and regulatory compliance.

Skills

Supplier Quality Engineering

CAPA

Non-conformances

Root-cause investigations

Regulatory compliance

Cross-functional collaboration

Change control

Quality documentation

Education

Engineering degree or related field

Job description

Maclivaro Limited is seeking a Supplier Quality Engineer for a 12-month freelance contract in Marlborough, MA or Delaware. This on-site role focuses on supplier quality, CAPA management, root-cause analyses and continuous improvement across the supply chain.

The ideal candidate has a strong medical device background, experience with ISO 13485 and FDA requirements, and can lead investigations while collaborating with Engineering, Manufacturing and Regulatory teams.