Quality Engineer III
Midmark Corporation
Summary
Identifies, investigates, plans, conducts, and leads activities to improve or ensure quality through design and manufacturing of medical devices and components. Cross-functionally collaborates with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components.
Job description
Job Summary
Identifies, investigates, plans, conducts, and leads activities to improve or ensure quality through design and manufacturing of medical devices and components. Cross-functionally collaborates with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components.
Essential/Primary Duties
- Ensures that products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.).
- Creates and assists in developing, maintaining, and improving the Quality Management System (QMS) to ensure compliance to all specified regulatory agencies.
- Drives product quality improvements internally and externally by working with design, manufacturing, and supply chain.
- Applies advanced tools and methods to solve complex problems. Tackles technical challenges and contributes to troubleshooting effort.
- Leads the application of six sigma techniques and drives continuous process improvement.
- Plans, implements, and optimizes complex solutions for small to medium sized projects and teams.
- Influences change within and across disciplines.
- Defines quality metrics, leads investigations, and communicates quality status.
- Leads or participates in cross-functional projects, defines KPIs, leads change management as the site-based quality department subject matter expert (SME).
- Facilitates the design and process failure mode and effects analysis (FMEA) process.
Secondary Duties
- Provides leadership, coaching, and/or mentoring to the co-op group and level I & II engineers.
- Supports, leads, or manages front room and/or back room for internal and external QMS audits and/or investigations.
- Understands engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records.
Education and/or Experience
Bachelor's degree in engineering or related field and 4+ years of relevant experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt and Certified Reliability Engineer (CRE) certifications are preferred.
Competency and/or Skill
- Fully understand basic engineering tools and methods
- Experience in the medical device industry and understanding of medical device quality systems and applications
- Ability to analyze existing processes and lead process improvement efforts
- Ability to apply advanced analytical tools and methods to solve complex problems
- Ability to lead the design of complex systems and identify new technological opportunities
Supervisory Responsibilities
- Provides leadership, coaching, and/or mentoring to level I and level II engineers.
Requirements
- Bachelor's degree in engineering or related field
- 4+ years of relevant experience
- Experience in the medical device industry
- Understanding of medical device quality systems and applications
- Knowledge of regulatory agencies (FDA, ISO, UL, CSA, etc.)
- Ability to analyze existing processes and lead process improvement efforts
- Ability to apply advanced analytical tools and methods to solve complex problems
- Ability to lead the design of complex systems and identify new technological opportunities
- Fully understand basic engineering tools and methods
Company overview
Midmark Corporation is a leading clinical environmental design company that transforms healthcare experiences through innovative design solutions for medical, dental, and animal health environments. Founded in 1915 and headquartered in Versailles, Ohio, Midmark employs over 2,200 teammates worldwide. The company specializes in harmonizing space, technology, and clinical workflows to create better care experiences for both caregivers and patients at the point of care. Midmark's comprehensive ecosystem includes medical equipment such as exam tables, diagnostic instruments, and sterilization systems; dental operatory solutions including chairs, cabinetry, and imaging systems; and veterinary equipment for animal health practices. With a focus on design-driven innovation, Midmark provides integrated solutions that enhance clinical efficiency, improve patient outcomes, and optimize operational workflows across healthcare settings. The company operates multiple innovation hubs and manufacturing facilities across the United States, with international subsidiaries in India and Italy, serving global healthcare markets with its "Designing better care" philosophy.