Quality Engineer Operations

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.

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).

• 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

• 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…