Supplier Quality Engineer - Medical Devices (12-Month)

Maclivaro Limited; Massachusetts; On-site; USD 110,000 - 150,000; Full time

Job summary

Maclivaro Limited is seeking a seasoned Supplier Quality Engineer for a 12-month freelance contract in Massachusetts or Delaware, USA. The role focuses on owning supplier-side quality, leading CAPA, audits, and QA investigations to maintain regulatory compliance across the supply chain.

You will collaborate with Engineering, Manufacturing, Procurement and Regulatory Affairs to resolve issues, implement corrective actions, and drive continuous improvement in medical device quality systems (ISO

Qualifications

• Engineering degree in Mechanical/ Biomedical/ Manufacturing or related field.
• Strong medical device industry experience required.
• Experience in supplier quality engineering within regulated devices.
• Knowledge of ISO 13485 and FDA requirements.
• Experience with CAPA, non-conformances and root-cause analysis.
• Independent, hands-on approach with cross-functional collaboration.

Responsibilities

• Oversee supplier quality activities ensuring regulatory compliance.
• Manage CAPA, non-conformances and root-cause investigations.
• Lead supplier quality investigations and remediation of recurring issues.
• Support CER-related activities and related documentation as applicable.
• Identify and resolve supplier and supply chain quality issues.
• Conduct supplier audits, assessments and ongoing performance monitoring.
• Collaborate with Engineering, Manufacturing, Procurement, Quality and Regulatory.
• Support supplier change control and risk assessments.
• Monitor supplier performance and drive continuous improvement.
• Ensure quality documentation and traceability per medical device regulations.

Skills

CAPA

Root cause analysis

Supplier quality

Cross-functional

Audits

Regulatory compliance

Quality investigations

Education

Engineering degree

Job description

Maclivaro Limited is seeking a seasoned Supplier Quality Engineer for a 12-month freelance contract in Massachusetts or Delaware, USA. The role focuses on owning supplier-side quality, leading CAPA, audits, and QA investigations to maintain regulatory compliance across the supply chain.

You will collaborate with Engineering, Manufacturing, Procurement and Regulatory Affairs to resolve issues, implement corrective actions, and drive continuous improvement in medical device quality systems (ISO