Quality Systems Director — FDA-Ready QMS & M&A Strategy

Medtronic plc; Plymouth (MN); On-site; USD 184,000 - 276,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) plan with employer match

Tuition assistance/reimbursement

Paid time off

Job summary

Medtronic seeks a Quality Director to lead the QMS and quality strategy for the PVH OU, including FDA inspection readiness and due diligence for acquisitions. This onsite role is based in Plymouth, MN with design and manufacturing sites in Minneapolis, Galway, Tijuana, Danvers, and Irvine.

The director will establish top-down quality KPIs, align OKRs with business objectives, and collaborate with cross-functional teams to strengthen regulatory compliance and operational effectiveness.

Qualifications

• Must have Baccalaureate with extensive managerial experience.
• Experience interacting with FDA during audits is preferred.
• Strong leadership and cross-functional collaboration required.

Responsibilities

• Lead the QMS and quality strategy for the PVH OU and oversee inspections.
• Drive quality KPIs and align OKRs with enterprise objectives.
• Participate in quality due diligence for acquisitions and integration planning.
• Collaborate with manufacturing sites to improve regulatory compliance.

Skills

FDA experience

QMSR experience

Leadership

Interpersonal skills

Project/program management

Quality orientation

Patient focus

Education

Bachelor's degree + 10+ yrs exp with 7+ mgr yrs

Advanced degree + 8+ yrs exp with 7+ mgr yrs

Job description

Medtronic seeks a Quality Director to lead the QMS and quality strategy for the PVH OU, including FDA inspection readiness and due diligence for acquisitions. This onsite role is based in Plymouth, MN with design and manufacturing sites in Minneapolis, Galway, Tijuana, Danvers, and Irvine.

The director will establish top-down quality KPIs, align OKRs with business objectives, and collaborate with cross-functional teams to strengthen regulatory compliance and operational effectiveness.