Quality Systems Leader: QMS, CAPA & Audits

Socket.dev; Plymouth (MN); On-site; USD 108,000 - 132,000; Full time

Job summary

Medtronic is seeking a Quality Systems Manager to lead the QMS at the Nathan Lane manufacturing site in Plymouth, MN. You will partner with Operations, Quality, Manufacturing Engineering, Supply Chain, and Regulatory teams to ensure compliant, effective systems that scale with the business.

The role drives audits, CAPA and document control, fostering a culture of quality and operational excellence while aligning with Medtronic's mission to alleviate pain and extend life.

Qualifications

• Experience in Quality Management System (QMS) processes incl. CAPA, nonconformance, change control, document control, training, or management review.
• Experience supporting FDA inspections, ISO 13485 and similar audits.
• ASQ certifications or equivalent preferred.

Responsibilities

• Lead development and maintenance of quality programs ensuring compliance with internal and external standards.
• Provide guidance interpreting policies and regulations to assure compliance.
• Drive continuous improvement and coordinate audits through all stages.

Skills

Quality systems

Regulatory compliance

Audit support

CAPA

Documentation control

Training

Management review

Continuous improvement

Process analysis

Education

Bachelor's degree in Engineering

Bachelor's degree in Quality

Bachelor's degree in Life Sciences

Advanced degree

Job description

Medtronic is seeking a Quality Systems Manager to lead the QMS at the Nathan Lane manufacturing site in Plymouth, MN. You will partner with Operations, Quality, Manufacturing Engineering, Supply Chain, and Regulatory teams to ensure compliant, effective systems that scale with the business.

The role drives audits, CAPA and document control, fostering a culture of quality and operational excellence while aligning with Medtronic's mission to alleviate pain and extend life.