Medical Engineering Consultants (MEC)
(Quality Engineer) Operations
Medical Engineering Consultants (MEC), Brooklyn Park, Minnesota, United States
Quality Engineer – Operations – Contract
Location: Maple Grove, Minnesota
MEC supports medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement 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’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. Their primary capabilities include balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.
Summary The Operations Quality Engineer will work closely with customers and the manufacturing team to ensure problems that arise in Receiving Inspection (RI) and the manufacturing lines are addressed quickly and corrective actions are implemented. The role focuses on continuous improvement and mistake proofing to ensure manufacturing lines run effectively and efficiently. Assignments include resolving and trending NCMRs, customer complaints, and Supplier Corrective Actions (SCARs), completing root cause analysis, and implementing Corrective and Preventative Actions (CAPA). The engineer will generate and execute process validation protocols (IQ/OQ/PQ) and support process risk management activities (pFMEA).
Essential Duties and Responsibilities
Function as the operation’s quality customer representative when projects are transferred to manufacturing
Support design transfer, verification of readiness for production, and ensure quality requirements are fully implemented
Lead NCMR, customer complaints, and CAPA investigation and reports; including troubleshooting manufacturing problems and ensuring compliance to procedures and requirements
Collaborate with suppliers on NCMRs and SCARs, escalating to Supplier Quality Engineering when appropriate
Participate in cross‑functional teams for the review and disposition of nonconforming products or components
Participate in cross‑functional teams to develop process validation and risk management files, including IQ/OQ/PQ protocols and reports and pFMEA documentation
Review completed Device History Record (DHR) documentation with a high degree of accuracy for Good Documentation Practices (GDP) and completeness
Support and advise project teams on Quality Policies / Procedures (including verification, validation, statistical methods, and manufacturing controls), when necessary
Assist in training of Special Work Orders (SWOs), Receiving Inspection Processes, and First Article Inspections (FAI) as required
Develop and implement error‑proofing mechanisms (poka‑yokes) to prevent defects and improve manufacturing processes
Assist in internal and process audits; may lead portions of audits as assigned
Technical Skills
Extensive expertise in manufacturing operations and quality systems in a medical device environment
Understanding of ISO 13485 and FDA QSR requirements including root cause analysis, risk management, and process validation
Root Cause Analysis (RCA) ability to define problems, collect data, establish facts and draw valid conclusions
ISO 13485 Lead Auditor certification preferred
Experience in eQMS systems, preferably Grand Avenue Software (GAS)
Experience with error‑proofing techniques (poka‑yokes) and their implementation in manufacturing environments
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
Familiarity with using inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules and microscopes
Excellent communication skills (written and verbal)
Conceptual Skills
Creative problem solver with good judgment
Independent work skills
High attention to detail and accuracy
Ability to manage, prioritize and execute multiple tasks
Positive, flexible outlook
Strong interpersonal communication skills with ability to communicate effectively across all levels
Education and Experience
Requires a B.S. degree in Science, Engineering or Technology or associated fields
Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971)
Working knowledge of the application of risk management, include pFMEA and process validation
3–5 years’ experience in Quality Engineering
5+ years’ experience in the medical device industry; catheter assembly preferred
Additional Information
Sponsorship is not available for this position
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
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MEC supports medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement 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’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. Their primary capabilities include balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.
Summary The Operations Quality Engineer will work closely with customers and the manufacturing team to ensure problems that arise in Receiving Inspection (RI) and the manufacturing lines are addressed quickly and corrective actions are implemented. The role focuses on continuous improvement and mistake proofing to ensure manufacturing lines run effectively and efficiently. Assignments include resolving and trending NCMRs, customer complaints, and Supplier Corrective Actions (SCARs), completing root cause analysis, and implementing Corrective and Preventative Actions (CAPA). The engineer will generate and execute process validation protocols (IQ/OQ/PQ) and support process risk management activities (pFMEA).
Essential Duties and Responsibilities
Function as the operation’s quality customer representative when projects are transferred to manufacturing
Support design transfer, verification of readiness for production, and ensure quality requirements are fully implemented
Lead NCMR, customer complaints, and CAPA investigation and reports; including troubleshooting manufacturing problems and ensuring compliance to procedures and requirements
Collaborate with suppliers on NCMRs and SCARs, escalating to Supplier Quality Engineering when appropriate
Participate in cross‑functional teams for the review and disposition of nonconforming products or components
Participate in cross‑functional teams to develop process validation and risk management files, including IQ/OQ/PQ protocols and reports and pFMEA documentation
Review completed Device History Record (DHR) documentation with a high degree of accuracy for Good Documentation Practices (GDP) and completeness
Support and advise project teams on Quality Policies / Procedures (including verification, validation, statistical methods, and manufacturing controls), when necessary
Assist in training of Special Work Orders (SWOs), Receiving Inspection Processes, and First Article Inspections (FAI) as required
Develop and implement error‑proofing mechanisms (poka‑yokes) to prevent defects and improve manufacturing processes
Assist in internal and process audits; may lead portions of audits as assigned
Technical Skills
Extensive expertise in manufacturing operations and quality systems in a medical device environment
Understanding of ISO 13485 and FDA QSR requirements including root cause analysis, risk management, and process validation
Root Cause Analysis (RCA) ability to define problems, collect data, establish facts and draw valid conclusions
ISO 13485 Lead Auditor certification preferred
Experience in eQMS systems, preferably Grand Avenue Software (GAS)
Experience with error‑proofing techniques (poka‑yokes) and their implementation in manufacturing environments
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
Familiarity with using inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules and microscopes
Excellent communication skills (written and verbal)
Conceptual Skills
Creative problem solver with good judgment
Independent work skills
High attention to detail and accuracy
Ability to manage, prioritize and execute multiple tasks
Positive, flexible outlook
Strong interpersonal communication skills with ability to communicate effectively across all levels
Education and Experience
Requires a B.S. degree in Science, Engineering or Technology or associated fields
Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971)
Working knowledge of the application of risk management, include pFMEA and process validation
3–5 years’ experience in Quality Engineering
5+ years’ experience in the medical device industry; catheter assembly preferred
Additional Information
Sponsorship is not available for this position
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
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