What are the responsibilities and job description for the Supplier Quality Engineer position at Medical Engineering Consultants (MEC)?
Job 2526 - Supplier Quality Engineer - Contract located near Maple Grove, MN
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.
Our Client is a contract manufacturer offering medical device prototyping, development, and manufacturing. Our primary capabilities are balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.
Summary
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.
Key Responsibilities (but Are Not Limited To)
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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.
Our Client is a contract manufacturer offering medical device prototyping, development, and manufacturing. Our primary capabilities are balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.
Summary
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.
Key Responsibilities (but Are Not Limited To)
- 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.
- Analyzes incoming material defects and communicates issues to suppliers.
- Develop, maintain, and improve receiving inspection and process documentation to ensure consistency and compliance Generates and maintains incoming inspection procedures.
- Assists 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 the ability to use 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 Degree in engineering or a related STEM field is preferred. Equivalent work experience or MBA may substitute.
- Minimum of 7 years experience in Supplier Quality Engineering in a medical device manufacturing/process development environment.
- Experience in planning and leading supplier audits
- Experience in a manufacturing team environment.
- Catheter assembly preferred.
- Sponsorship is not available for this position
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.