Quality Engineer

Quality Engineer (Contract) – Minneapolis, 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 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 SMEs. MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

This Quality Engineer on the Field CAPA and Design Quality team will lead cross‑functional teams to determine actionable root cause and implement effective solutions for high‑visibility issues impacting Active Implantable Accessories product performance within our client’s CRM division. The role is for a strong technical individual with innate curiosity who seeks leadership, complex problem solving, and project management experience. The engineer will collaborate with R&D, Regulatory, Marketing, Medical Safety, Manufacturing, Post‑Market and other Quality organizations to achieve optimal results, and support other Design Quality work on risk management, new product development, and sustainment.

• Lead cross-functional teams on complex investigations where suspected root cause is product design—including NCEPs, CAPAs, and field action recommendations.
• Lead collaborative problem solving of complex technical issues using disciplined methodology (DMAIC, Root Cause Analysis, etc.).
• Create, maintain and enhance cross‑functional partnerships.
• Provide guidance regarding technical strategies, work cross‑functionally at multiple sites to resolve issues.
• Represent the team at key global and divisional leadership forums.
• Create and maintain detailed investigation documentation following Good Documentation Practice guidelines.
• Create, review, and approve Quality System records for NCEPs and CAPAs.
• Present updates in formal and informal reviews with all levels of the organization, including high senior leadership.
• Mentor and guide other cross‑functional teams with technical guidance and consulting on NCEPs and CAPAs execution.
• Consult across other client divisions as needed.
• Champion continuous improvement by fostering execution of projects within local and divisional Design Assurance.
• Promote a diverse and inclusive workplace enabling all participants to contribute to their full potential.
• Monitor and ensure compliance with company policies and procedures.
• Demonstrate primary commitment to patient safety and product quality by maintaining compliance to the Quality Systems.

Build quality into all aspects of the work by maintaining compliance with all quality requirements, quality policy, and documented quality processes and procedures.

• Bachelor’s degree in engineering or related discipline plus 4 years of relevant experience.
• Knowledge of Quality System Regulations, Medical Device Regulation, and ISO 13485.
• Experience in the medical device industry.
• Experience with non‑conforming products/processes, CAPAs, field action, and investigation processes.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

• Experience with active implantable medical technologies.
• Demonstrated technical problem‑solving data analysis capabilities.
• Experience with statistics and statistical analysis tools (e.g., MINITAB, Weibull).
• Strong ability to multitask and adapt.
• Project management experience, directly or cross‑functional teams.
• Business acumen and communication skills for rapid impact assessment.
• Ability to influence across multiple cross‑functional teams.
• Experience managing and leading multiple projects covering diverse engineering disciplines.
• Self‑starter who identifies improvement opportunities.
• Comfort speaking to groups including divisional senior leaders.

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.