Lead Quality Engineer – Medical Devices

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

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