Quality Engineering Manager; Medical Device

Job 2528 - (Quality Engineer Manager) Operations - Contract located near Maple Grove, Minnesota

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. Their primary capabilities are balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.

Oversee and manage all Operations Quality Engineering personnel and processes. The Operations Quality Engineer Manager will be responsible for the NCMR system in Grand Avenue (GAS) and will work with internal and external teams to solve manufacturing problems. The Manager will also be working with suppliers on any problems with supplied parts and conducting supplier audits as needed.

• Manage, mentor, and coach Operations Quality Engineers on quality standards and best practices. Provide job direction, training and conduct performance reviews.
• Manage the NCMR system in Grand Avenue (GAS) including tracking and trending NCMRs to identify CAPAs as required.
• Communicate nonconformance issues across all levels of the organization.
• Lead CAPA Investigations and implementation of corrective actions to ensure thorough investigation, effectiveness and timely completion.
• Manage manufacturing quality problems through systematic root cause analysis, data-driven decision making, and cross-functional collaboration.
• Create Master Validation Plans for processes transferring to manufacturing.
• Support process validation activities including protocol development, execution oversight and report approval.
• Identify supplier issues and drive improvements to reduce incoming non-conformances.
• Manage supplier quality relationships and facilitate corrective action implementation as needed.
• Conduct supplier and process audits as needed to ensure compliance with quality standards and regulatory requirements.
• Implement Statistical Process Controls (SPC) on production lines to monitor process capabilities and drive continuous improvement.
• Develop and implement error-proofing mechanisms (poka-yokes) to prevent defects and improve manufacturing processes.
• Support risk management activities in accordance with ISO 14971, including participation in pFMEA creation and updates.
• Maintain and oversee content of the Device Master Record (DMR) to ensure accuracy and compliance.
• Audit Design History File (DHF) for completeness and accuracy.
• Support internal and external audits, including client audits conducted on the Operations level.
• Participate and lead response to audit findings.

• Extensive expertise in manufacturing operations and quality systems in a medical device environment.
• Deep understanding of ISO 13485 and FDA QSR requirements including design controls, risk management, and process validation.
• ISO 13485 Lead Auditor certification.
• Experience conducting supplier audits and process audits.
• Experience in eQMS systems, preferably GAS.
• Experience with error proofing techniques (poka-yokes) and their implementation in manufacturing environments.
• 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…