Quality Systems Lead – Medical Devices

Medtronic; Iowa (LA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with employer match

Paid time off

Employee Stock Purchase Plan

Job summary

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

You will drive CAPA, audits, document control, training, and management review, foster a culture of quality, and support FDA and ISO audits.

Qualifications

• Bachelor’s degree with minimum 5 years relevant experience, or advanced degree with minimum 3 years prior relevant experience.
• Experience supporting Quality Management System (QMS) processes, including CAPA, nonconformance, change control, document control, training, or management review.
• Experience supporting FDA inspections, ISO 13485 audits, MDSAP audits, customer audits, or internal quality audits.
• Experience interpreting and applying FDA Quality System Regulation, ISO 13485, MDSAP, or other regulated quality system requirements.
• Experience supporting quality systems within medical device, pharmaceutical, biotechnology, or other regulated industries.
• Experience partnering with Manufacturing, Operations, Engineering, Regulatory Affairs, or Supply Chain functions.
• Experience developing, monitoring, or reporting quality system metrics.
• Experience supporting quality systems in a manufacturing environment.
• Experience leading quality, compliance, audit, or continuous improvement projects.
• ASQ certifications such as CQE, CQA, CMQ/OE or equivalent.

Responsibilities

• Oversee development and maintenance of quality programs, systems, processes and procedures to ensure compliance with policies and guidelines.
• Provide guidance interpreting policies and regulations to assure compliance.
• Collaborate with operating entities to enforce requirements and meet regulations.
• Lead audit and inspection preparation and coordinate findings resolution with inspectors.
• Prepare reports and documentation (e.g., CAPA) for stakeholders.
• Coordinate legal requests in support of investigations or litigations.
• Maintain and update quality assurance programs and policies.
• Foster uniform standards worldwide and share best practices to support Medtronic’s mission.

Skills

Quality Systems

CAPA

Audits

Regulatory compliance

Cross-functional collaboration

Document control

Continuous improvement

Quality metrics

FDA inspections

ISO 13485

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical field

ASQ certification (CQE, CQA, CMQ/OE) or equivalent

Job description

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

You will drive CAPA, audits, document control, training, and management review, foster a culture of quality, and support FDA and ISO audits.