Quality Engineer II

Regulatory Jobs; Ohio; On-site; USD 90,000 - 130,000; Full time

Job summary

Midmark Corporation is seeking a Quality Engineer to identify, investigate, plan, conduct, and lead activities that improve or ensure quality in the design and manufacturing of medical devices and components. The role collaborates cross-functionally with R+D engineering, manufacturing, technical service, and supply chain to manage quality, regulatory compliance, and cost.

The ideal candidate has a bachelor’s degree in engineering or related field with 4+ years of relevant experience, and

Qualifications

• 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

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

Skills

Regulatory knowledge

QMS expertise

FMEA facilitation

Process improvement

Cross-functional leadership

Data analysis

Quality engineering

Education

Bachelor's degree in engineering or related field

CQE (Certified Quality Engineer)

Six Sigma Black Belt

CRE (Certified Reliability Engineer)

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.