Quality Systems Leader: QMS Excellence & Compliance

COV Covidien LP; Plymouth (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) with employer match

Paid time off

Tuition assistance/reimbursement

Employee Stock Purchase Plan

Employee Assistance Program

Job summary

Medtronic in Plymouth, Minnesota seeks a Quality Systems Manager to lead the Quality Management System at the Nathan Lane site. You will collaborate with Operations, Quality, Manufacturing Engineering, Regulatory, and Supply Chain to ensure compliant, effective quality systems that scale with the business.

The role emphasizes CAPA, document control, training, audits, and management review while advancing Medtronic's mission to alleviate pain, restore health, and extend life.

Qualifications

• Bachelor's degree with 5+ years relevant experience, or advanced degree with 3+ years prior relevant experience.
• Experience supporting FDA inspections, ISO 13485 audits, MDSAP audits, customer audits, or internal quality audits.
• ASQ certification such as CQE, CQA, CMQ/OE, or equivalent.
• Experience partnering with Manufacturing, Operations, Engineering, Regulatory Affairs, or Supply Chain.

Responsibilities

• Oversight for quality programs, systems, processes ensuring compliance with policies and standards.
• Guidance interpreting policies and regulations to assure compliance.
• Lead audit/preparation and coordinate with inspectors through all stages.
• Prepare reports and documentation for stakeholders, including CAPAs.
• Drive uniform global standards and share best practices to support the mission.

Skills

Quality management

Regulatory compliance

Auditing

Cross-functional collaboration

CAPA leadership

Education

Bachelor's in Engineering/Quality/Life Sciences

ASQ CQE/CQA/CMQOE

Job description

Medtronic in Plymouth, Minnesota seeks a Quality Systems Manager to lead the Quality Management System at the Nathan Lane site. You will collaborate with Operations, Quality, Manufacturing Engineering, Regulatory, and Supply Chain to ensure compliant, effective quality systems that scale with the business.

The role emphasizes CAPA, document control, training, audits, and management review while advancing Medtronic's mission to alleviate pain, restore health, and extend life.