Quality Systems Leader - Medical Devices & Compliance

Medtronic; Plymouth (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Dental & Vision insurance

401(k) with match

Tuition assistance

Job summary

Medtronic in Plymouth, Minnesota, seeks a Quality Systems Manager to lead the QMS at the Nathan Lane site, guiding CAPA, document control, audits, training and management review to ensure compliance and continuous improvement.

You will partner with Operations, Quality, Manufacturing Engineering, Regulatory, and Supply Chain to scale the business and drive a culture of quality in line with Medtronic's mission to alleviate pain, restore health, and extend life.

Qualifications

• Experience leading Quality Management System (QMS) programs and CAPA processes.
• Experience interpreting FDA/ISO quality requirements and audits.
• Ability to drive continuous improvement and key quality metrics.
• Experience in regulatory/regulatory-inspection environments (FDA/ISO/MDSAP).
• Strong cross-functional collaboration with Operations, Regulatory, and Quality teams.

Responsibilities

• Oversee development and maintenance of quality programs, systems, and procedures.
• Lead audit and inspection preparation and manage findings with stakeholders.
• Coordinate legal requests supporting investigations or litigations.
• Ensure QA policies are maintained and updated regularly.
• Foster global standardization and share best practices across sites.

Skills

Quality management

CAPA

Audits

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree

Job description

Medtronic in Plymouth, Minnesota, seeks a Quality Systems Manager to lead the QMS at the Nathan Lane site, guiding CAPA, document control, audits, training and management review to ensure compliance and continuous improvement.

You will partner with Operations, Quality, Manufacturing Engineering, Regulatory, and Supply Chain to scale the business and drive a culture of quality in line with Medtronic's mission to alleviate pain, restore health, and extend life.