Senior Quality Program Manager (Medtech)

TL;DR

Senior Quality Program Manager (Medtech): Leading compliance and product quality improvements for Neuromodulation products with an accent on regulatory expectations and global impact. Focus on executing high-visibility programs, identifying issue resolution through CAPA, and ensuring technical excellence in medical device quality.

Location: Onsite in Fridley, MN (4 days a week). Requires 25%-50% travel.

Salary: $178,400 - $267,600

Company

Global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Lead a high-performing program team to execute compliance and product quality improvements for Neuromodulation products.
• Manage program execution, issue identification, and resolution through the CAPA process to ensure the highest level of compliance.
• Present program plans, risks, and progress to executive leadership committees.
• Collaborate with the quality leadership team to influence business strategy, customer experience, and product safety.
• Engage with internal Centers of Expertise, the FDA, notified bodies, and industry working groups to maintain alignment with best practices.

Requirements

• Bachelor’s degree with minimum 7 years of experience in the medical device industry, OR an advanced degree with 5+ years.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Proven experience in medical device quality systems, compliance, or post-market quality programs.

Nice to have

• Knowledge of FDA and ISO standards, including ISO 13485 and ISO 14971.
• Experience with design controls, risk management, and CAPA.
• Experience managing design and/or manufacturing transfers.
• Proficiency with quality improvement tools such as Six Sigma, FMEA, FTA, or DOE.

Culture & Benefits

• Competitive base salary and eligibility for the hirify.global Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance, including HSA and Flexible Spending Accounts.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and Employee Stock Purchase Plan.
• Tuition assistance/reimbursement and a global well-being program (Simple Steps).