Global Quality Engineering Leader – Medical Devices

LDI Search LTD.; Nebraska; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Leadership position in a world-class company

Opportunity for career advancement

Influence on quality engineering strategy

Job summary

A global medical device manufacturer is seeking a Quality Engineering Manager to lead their quality function in Nebraska. This leadership role combines technical expertise and team development, offering significant impact on product quality and regulatory compliance. Responsibilities include developing quality strategies, overseeing validation activities, and driving continuous improvement initiatives like Lean and Six Sigma. Ideal candidates will have relevant engineering degrees, leadership experience in regulated environments, and a track record in medical device manufacturing.

Qualifications

• Proven track record in medical device or pharmaceutical manufacturing.
• Experience in validation, PFMEA, and quality systems.
• Demonstrable leadership experience in a regulated environment.

Responsibilities

• Lead the development and implementation of quality engineering strategies.
• Provide oversight for validation activities and vendor qualification programmes.
• Act as primary representative during FDA, ISO, and third-party audits.
• Drive continuous improvement through Lean and Six Sigma methodologies.

Skills

Leadership

Quality Assurance

Six Sigma

Statistical Methods

Risk Management

Education

Degree in Engineering, Quality Assurance, Mathematics/Statistics or related

Master’s degree (advantageous)

Job description

A global medical device manufacturer is seeking a Quality Engineering Manager to lead their quality function in Nebraska. This leadership role combines technical expertise and team development, offering significant impact on product quality and regulatory compliance. Responsibilities include developing quality strategies, overseeing validation activities, and driving continuous improvement initiatives like Lean and Six Sigma. Ideal candidates will have relevant engineering degrees, leadership experience in regulated environments, and a track record in medical device manufacturing.