Quality Control Operations Lead – Medical Devices

Regulatory Jobs; Brooklyn Park (MN); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

401k match

Onsite health clinics

Discretionary holiday bonus

Cretex University

Job summary

Cretex Medical, a leading contract manufacturer for medical devices, seeks a Quality Control Manager to lead Incoming, In-Process, Final Inspection and Quality Laboratory functions, while aligning with NPD and Manufacturing to ensure compliant product realization and operational excellence.

You will set direction, coach teams, manage KPIs, and drive risk-based quality and regulatory compliance, using data-driven tools and continuous improvement to deliver first-time quality.

Qualifications

• Bachelor's degree in engineering or related field.
• 5+ years in Quality Control or Manufacturing Quality.
• Strong FDA 21 CFR 820 and ISO 13485 knowledge.
• 5+ years of Leadership experience.
• Lean/Six Sigma experience.
• High-mix manufacturing environment experience.
• Strong data and problem-solving skills.

Responsibilities

• Lead Inspection and Quality Control teams across Incoming, In-Process, Final Inspection, and Quality Laboratory; align with site quality, safety, delivery and cost targets.
• Own end-to-end inspection and quality control lifecycle; define standardized work, sampling plans and change control.
• Lead initiatives to improve first-time-right quality, reduce cycle time, and lower cost of poor quality.
• Partner with Design, Operations, Engineering and Quality to align inspection strategy with manufacturing execution; communicate trends and actions to site leadership.

Skills

Leadership

Quality management

Regulatory knowledge

Data analysis

Problem solving

Education

Bachelor's degree in engineering

Job description

Cretex Medical, a leading contract manufacturer for medical devices, seeks a Quality Control Manager to lead Incoming, In-Process, Final Inspection and Quality Laboratory functions, while aligning with NPD and Manufacturing to ensure compliant product realization and operational excellence.

You will set direction, coach teams, manage KPIs, and drive risk-based quality and regulatory compliance, using data-driven tools and continuous improvement to deliver first-time quality.