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.
Work Authorization:
Midmark Corporation will only employ those who are legally authorized to work in the United States. This is not a position for which sponsorship will be provided. Individuals with temporary visas or who need sponsorship for work authorization now or in the future, are not eligible for hire.