Vice President, QARA (CRMN)

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers' success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Are you ready to lead quality excellence at the forefront of medical innovation?

The Vice President of Quality Assurance & Regulatory Affairs - CRMN is responsible for all aspects of quality assurance and regulatory affairs within Integer's Cardiac Rhythm Management & Neuromodulation (CRMN) product category. This portfolio covers the design, development, and manufacture of critical devices and components that enable life-sustaining CRM therapies and cutting-edge neuromodulation procedures.

This is a high-paced, high-impact leadership role at the heart of Integer's mission to enhance patient lives worldwide. As a trusted partner to the world's leading medical device innovators, Integer plays a pivotal role in the global medtech ecosystem-bringing deep technical expertise, rigorous quality standards, and flawless execution to technologies that restore rhythm, manage pain, and improve quality of life for millions of patients.

The VP leads operational quality across CRMN manufacturing sites, ensures regulatory compliance for products where Integer holds approvals, and serves as the principal quality liaison with customers in this category. They oversee the Product Development Process (PDP) and New Product Introduction (NPI) for CRMN, ensuring new products launch with uncompromising quality and reliability. This role requires balancing strategic leadership with hands-on problem-solving in a fast-paced, innovation-driven environment.

Accountabilities & Responsibilities

• Quality & Regulatory Leadership for CRMN - Lead all QA/RA activities for CRMN, ensuring compliance to EN ISO 13485, EU MDR, 21 CFR Part 820, and other applicable global regulations.
• Strategic Partner to the Product Category - As a member of the CRMN leadership team, shape category strategy, influence operational facility planning, and align quality initiatives with business growth priorities.
• Customer-Facing Quality Advocate - Serve as the principal quality contact for the world's top medtech OEMs in CRMN, participating in executive business reviews, partnership meetings, and escalation resolution.
• Operational Excellence Across Sites - Provide leadership to site QA Managers, Design Assurance teams, Supplier Quality, and Document Control to ensure manufacturing of CRMN products meets or exceeds all quality and performance standards.
• Regulatory Affairs Support - Partner with the centralized RA team to manage product registrations, regulatory submissions, and post-market surveillance for Integer-owned CRMN devices.
• PDP/NPI Leadership - Drive robust design assurance, risk management, verification, and validation for new CRMN products, ensuring first-to-market launches are also best-in-quality.
• Continuous Improvement - Establish annual quality metric targets for CRMN, partner with Operations and Engineering to execute data-driven improvement plans, and implement lessons learned from product and process changes.
• Cross-Functional Influence - Build strong relationships with Enterprise QA/RA, Operations, Commercial, and Engineering teams to standardize best practices and advance Integer's culture of quality.
• Patient-First Decision Making - Identify, escalate, and resolve any quality issues that could impact patient safety, therapy effectiveness, or regulatory compliance.
• Team Development - Recruit, mentor, and develop high-performing quality and regulatory leaders in the CRMN space, ensuring succession readiness and technical excellence.

Education & Experience

• Required: BS in engineering, technical, or related discipline; MS preferred.
• Experience: Minimum 12 years in Quality Assurance in medical device development/manufacturing, with 5+ years in multi-site leadership. Direct experience in cardiac rhythm management, neuromodulation, or other Class III active implantable medical devices strongly preferred.

Knowledge & Skills

• Proven ability to lead in a highly regulated, innovation-driven environment where product reliability and patient safety are paramount.
• Deep understanding of product development for active implantable devices, including verification, validation, risk management, and regulatory submissions.
• Strong track record of building quality organizations that enable innovation while maintaining compliance.
• Expertise in advanced problem-solving tools (Six Sigma Black Belt, SPC, DOE, ANOVA) and continuous improvement methodologies.
• Ability to influence cross-functional teams and represent Integer as a strategic partner to major medtech OEMs.
• Excellent communication, strategic thinking, and leadership skills with the ability to inspire teams in a mission-critical, patient-focused environment

Salary Range: $242,250 - $355,300

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer's success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. Employees at the level of Vice President and above are eligible to receive stock awards as part of their annual compensation package. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance.Employees are immediately eligible to participate in the 401(k) and Savings Restoration plans with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.