[Hiring] Senior Quality Manager @Integer Holdings Corporation

Role Description

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

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related technical field required.
• 8+ years of experience in Quality, IT, Operations, or related functions within an FDA regulated environment.
• 3+ years of supervisory or leadership experience.
• Experience implementing, validating, governing, or sustaining technologies used in FDA-regulated environments, including QMS, MES, LMS, and related enterprise platforms.
• Ability to drive adoption of new technology by balancing compliance, user experience, business value, and operational practicality.

Requirements

• Strong working knowledge of regulated quality technology, including CSV/CSA, electronic records, data integrity, and lifecycle governance.
• Working knowledge of medical device quality system requirements, including EU MDR, ISO 13485, ISO 9001, GMP, 21 CFR 820, Good Documentation Practices, FDA CSA Guidance, and audit expectations.
• A continuous improvement mindset and strong drive to overcome challenges in achieving goals and delivering results.
• Ability to translate complex regulatory, technical, and business needs into practical requirements, governance models, and implementation plans.
• Strong cross-functional leadership, concise communication and influence skills across Quality, IT, Operations, Engineering, Regulatory, and site leadership.
• Ability to build, lead, and develop global teams while communicating clearly with executive, technical, regulatory, and frontline audiences.

Benefits

• 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) plan with company matching contributions.
• 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

Salary Range

$128,250.00 - $188,100.00

Company Description

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