Quality Engineer III

Midmark Corporation•Versailles, OH

About The Position

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.

Requirements

Bachelor's degree in engineering or related field and 4+ years of relevant experience, or equivalent combination of both.
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
Provides leadership, coaching, and/or mentoring to level I and level II engineers.

Nice To Haves

Certified Quality Engineer (CQE), Six Sigma Blackbelt and Certified Reliability Engineer (CRE) certifications are preferred.

Responsibilities

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.
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.