Supplier Quality Engineer

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

Supplier Quality Engineer | Medical Devices | 12-Month Contract

Massachusetts or Delaware, USA | On-Site

12-Month Freelance Contract

The Opportunity

A global medical device manufacturing company is looking for an experienced Supplier Quality Engineer to join its team on a 12-month freelance contract.

This is an excellent opportunity for an engineer with a strong medical device background to take ownership of supplier-side quality, working closely with suppliers, manufacturing, engineering and internal quality teams to resolve issues, drive corrective actions and maintain regulatory compliance across the supply chain.

We are looking for someone who understands the technical and regulatory demands of medical device manufacturing and can take a hands-on, proactive approach to supplier quality management.

Key Responsibilities

• Oversee supplier quality activities, ensuring suppliers meet medical device quality and regulatory requirements.
• Manage supplier corrective and preventive actions (CAPA), non-conformances, root-cause investigations and effectiveness checks.
• Lead supplier-related quality investigations and drive timely resolution of recurring issues.
• Support and oversee CER-related activities and documentation, where applicable to supplier quality and regulatory requirements.
• Identify, assess and resolve supplier and supply chain quality issues that could impact product quality, manufacturing continuity or regulatory compliance.
• Conduct supplier audits, assessments, qualification and ongoing performance monitoring.
• Collaborate with Engineering, Manufacturing, Procurement, Quality and Regulatory Affairs to address technical issues and implement sustainable solutions.
• Support supplier change control, risk assessments and quality agreements.
• Monitor supplier performance, identify improvement opportunities and drive continuous improvement across the supply chain.
• Ensure appropriate quality documentation, traceability and compliance with applicable medical device regulations and standards.

About You

• An engineering degree or equivalent technical background, ideally in Mechanical, Biomedical, Manufacturing or a related engineering discipline.
• Strong, demonstrable experience within the medical device industry, ideally in a manufacturing or product development environment.
• Proven experience in Supplier Quality Engineering or supplier-facing quality engineering within regulated medical devices.
• Strong knowledge of medical device quality systems, including ISO 13485 and applicable FDA requirements.
• Experience managing supplier corrective actions, CAPA, non-conformances, root-cause analysis and supplier quality investigations.
• Understanding of supplier risk management, quality audits, change control and supply chain quality issues.
• Confident working cross-functionally with suppliers and internal engineering, manufacturing and quality stakeholders.
• A practical, hands-on approach with the ability to independently investigate issues and drive them through to resolution.
• Contract: 12 months, freelance
• Location: On-site in Massachusetts or Delaware, USA
• Industry: Medical Devices / Global Manufacturing