Quality Systems Program Director (Medtech)

TL;DR

Quality Systems Program Director (Medtech): Leading the Quality Management System (QMS) and quality strategy for the PVH Operating Unit with an accent on FDA compliance, regulatory inspections, and quality due diligence for acquisitions. Focus on establishing quality KPIs/OKRs, managing QMSR requirements, and leading front-room activities during FDA audits.

Location: Onsite in Plymouth, MN, USA

Salary: $184,000 - $276,000

Company

Global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

• Lead the Quality Management System (QMS) and overall quality strategy for the PVH Operating Unit.
• Oversee FDA inspection readiness and act as the front-room leader during QMSR inspections.
• Drive quality strategy for the PCH OU by establishing top-down KPIs and aligning operational OKRs.
• Conduct quality due diligence, risk assessment, and integration planning for mergers and acquisitions.
• Collaborate with manufacturing sites to implement quality standards and regulatory best practices.
• Drive continuous improvement initiatives to enhance regulatory compliance and operational effectiveness.

Requirements

• Baccalaureate with 10+ years of experience and 7 years of managerial experience (or Advanced degree with 8 years total and 7 years managerial).
• Must possess unrestricted U.S. work authorization (Sponsorship offered only for Principal-level roles and above).
• Experience leading quality strategies and organizational OKRs.
• Ability to lead and manage dotted-line teams across multiple geographic sites.

Nice to have

• Demonstrated experience interacting with the FDA during audits.
• Expertise in Quality Management System Regulation (QMSR).
• Proven ability to reduce compliance gaps in manufacturing sites.
• Strong project and program management skills.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Annual long-term incentive plan (LTIP) and short-term incentive (MIP).
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Tuition assistance/reimbursement and a global well-being program (Simple Steps).