Quality Engineering Manager

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

Quality Engineering Manager – Medical Devices

Our client is global medical device manufacturer – we are partnering with them in their search to appoint a Quality Engineering Manager to lead/develop their quality function within one of their largest and highest profile US facilities. This role offers the opportunity to make a significant impact on product quality, regulatory compliance, and operational excellence within a highly regulated and fast-moving sector. The successful candidate will provide strategic direction across quality engineering activities, ensuring robust systems are in place to deliver safe, effective products and meet global regulatory standards. This is a leadership role, combining technical expertise with team development, and offering visibility across the wider international organisation.

Key Responsibilities

• Lead the development and implementation of quality engineering strategies, systems, and processes to support manufacturing objectives.
• Provide oversight for validation activities, product and process changes, and vendor qualification programmes.
• Act as the primary engineering representative during FDA, ISO, and third-party audits.
• Drive continuous improvement through Lean, Six Sigma, and advanced problem-solving methodologies.
• Build capability within the quality engineering team through mentoring, coaching, and recruitment.
• Partner with global quality and manufacturing leaders to ensure alignment and best practice sharing.

Candidate Profile

• Degree-qualified in Engineering, Quality Assurance, Mathematics/Statistics, or a related scientific discipline; Master’s degree advantageous.
• Proven track record in medical device or pharmaceutical manufacturing, with experience in validation, PFMEA, and quality systems.
• Demonstrable leadership experience, ideally within a regulated environment.
• Strong knowledge of quality tools, statistical methods, and risk management processes.
• Experience of project management, CAPA, and continuous improvement methodologies; Six Sigma certification desirable.

This appointment offers

• A leadership position within a world-class medical technology business.
• The opportunity to shape and influence quality engineering strategy at both plant and global level.
• A highly visible platform for further career advancement.

For a confidential discussion, please contact us.