Supplier Quality Engineer

Supplier Quality Engineer (Contract) – Job 2526

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients' needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long‑term support—from high‑end leaders, managers and consultants to skill‑set Engineering staff and SME's (Subject Matter Experts). MEC's mission is to inspire positive cultural change from within, and always exceed our clients' expectations.

Client: a contract manufacturer offering medical device prototyping, development, and manufacturing. Primary capabilities include balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.

The Supplier Quality Engineer collaborates with suppliers, manufacturing, development, and supply chain teams to investigate supplied component nonconformances, implement corrective actions, and drive continuous improvement. Additional responsibilities include conducting supplier assessments and audits, maintaining compliant documentation, and ensuring adherence to FDA 21 CFR Part 820 and ISO 13485 standards.

• Investigate and resolve supplier‑related NCMRs that impact product quality, manufacturing, or business performance.
• Drive improvement and corrective action (SCARs) for components sourced from suppliers.
• Analyze incoming material defects and communicate issues to suppliers.
• Develop, maintain, and improve receiving inspection and process documentation to ensure consistency and compliance and generate incoming inspection procedures.
• Assist in generating component specifications.
• Collaborate with suppliers through meetings, audits, and reviews to identify risks, drive corrective actions, and improve quality outcomes.
• Plan and lead supplier audits to maintain compliance with applicable standards.
• Complete supplier assessments and evaluations.
• Evaluate and support supplier changes for potential effects on design, quality, and regulatory compliance for manufacturing and development projects.
• Participate in risk management activities such as FMEA development and updates.

• Extensive expertise in supplier management and quality systems in a medical device environment.
• ISO 13485 Lead Auditor certification.
• Experience conducting supplier audits.
• Understanding of ISO 13485 and FDA QSR requirements including design controls, risk management, and process validation.
• Experience in eQMS systems, preferably GAS.
• Root Cause Analysis (RCA) including ability to define problems, collect data, establish facts and draw valid conclusions.
• Highly proficient with MS Office (Word, Excel, Access and PowerPoint), internet and e‑mail systems.
• Solid understanding of software capabilities and business applications.
• Ability to accurately prioritize and execute with minimal direction.
• Ability to interpret and understand drawing specifications, tolerances, procedures for inspection and the application of sampling plans.
• Familiar with using inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules and microscopes.
• Broad knowledge of theory and principles of statistics and statistical process control.
• Excellent communication skills (written and verbal).

• Strong interpersonal communication skills with the ability to effectively communicate with suppliers.
• Creative problem solver coupled with good judgment.
• Independent work skills.
• High attention to detail and accuracy.
• Ability to manage, prioritize and execute multiple tasks.
• Positive, flexible outlook.

• Bachelor’s Degree in engineering or a related STEM field is preferred. Equivalent work experience or MBA may substitute.
• Minimum of 7+ years…