Senior Medical Device Quality Engineer & QMS Lead

Midmark Corporation; Versailles (OH); On-site; USD 85,000 - 105,000; Full time

Job summary

A leading medical device company in Versailles, Ohio, seeks a Quality Manager to oversee quality systems and ensure regulatory compliance. This position involves driving product quality improvements, managing cross-functional teams, and mentoring engineering staff. The ideal candidate holds a degree in engineering, possesses 6+ years of relevant experience, and has certifications like CQE and Six Sigma Blackbelt. This role offers a dynamic opportunity to shape quality practices in healthcare technology.

Qualifications

• 6+ years of relevant experience in the medical device sector.
• Leadership abilities for engineers and technicians.
• Experience with Six Sigma projects and quality management systems.

Responsibilities

• Ensure compliance with regulatory agencies like FDA and ISO.
• Develop and maintain the Quality Management System.
• Drive continuous process improvement and product quality.
• Lead cross-functional teams in technical decision-making.

Skills

Medical device industry experience

Understanding of medical device quality systems

Leadership and mentoring

Problem-solving

Influencing and negotiating

Education

Bachelor's degree in engineering or related field

Certified Quality Engineer (CQE)

Six Sigma Blackbelt

Certified Reliability Engineer (CRE)

Job description

A leading medical device company in Versailles, Ohio, seeks a Quality Manager to oversee quality systems and ensure regulatory compliance. This position involves driving product quality improvements, managing cross-functional teams, and mentoring engineering staff. The ideal candidate holds a degree in engineering, possesses 6+ years of relevant experience, and has certifications like CQE and Six Sigma Blackbelt. This role offers a dynamic opportunity to shape quality practices in healthcare technology.