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Open nowPosted 28 days ago

Quality Engineer II

Midmark Corporation43 open roles

Where
Versailles, OH, United States
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Your applicationOpen nowQuality Engineer IIMidmark Corporation · Versailles, OH, United States

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The clock on this job

Early applications get read.

12.7% of postings close within 7 days. Measured by our own scanner across the market. Midmark Corporation postings stay open a median of 15 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.7%7 days
  4. 20.4%14 days
  5. 35.6%30 days
  6. 58.7%60 days
This job: posted 28 days ago

Midmark Corporation median: 15 days open

The posting

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.

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.

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