Logo for Integer Holdings Corporation

Senior Quality Manager, Technology

Role overview

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related technical field
  • 8+ years of experience in Quality, IT, Operations, or related functions within an FDA regulated environment
  • 3+ years of supervisory or leadership experience
  • Strong working knowledge of regulated quality technology

Responsibilities

  • Partner with Global Quality Systems leadership to define QMS technology strategy and priorities
  • Ensure requirements and compliance are maintained through the system lifecycle
  • Drive adoption of data-driven and AI-enabled approaches for regulated quality technology
  • Lead, coach, and develop a team responsible for digital quality enablement

Key facts

  • Remote from: United States
  • Full time
  • Senior (5-10 years)
  • Quality Manager
  • English

Hard skills

Other skills

  • Communication
  • Team Leadership
  • Coaching
  • Decision Making

About the company

Integer Holdings Corporation logo

Integer Holdings Corporation

Contract Development & Manufacturing Organizations (CDMO)

Integer Holdings Corporation (NYSE:ITGR) is a leader in advanced medical device outsourcing (MDO) and serves its customers by providing comprehensive end-to-end solutions with its unparalleled expertise in innovation and manufacturing. Integer's vision is to enhance the lives of patients worldwide by being its customer's partner of choice for innovative medical technologies and services. Additionally, through Electrochem, an Integer company, it develops custom batteries for high-end niche applications in energy, military, and environment markets. The company's medical device manufacturing brands include Greatbatch™ Medical and Lake Region Medical™. Additional information is available at www.integer.net.

Company details

Company typeXLarge
IndustryContract Development & Manufacturing Organizations (CDMO)
Company size10001

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job 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




Accountabilities & Responsibilities:

Strategy, Roadmap & Value Acceleration

  • Partner with Global Quality Systems leadership to define QMS technology strategy, annual priorities, roadmaps, and measurable objectives.
  • Align stakeholders on standard, scalable technology solutions that support business strategy, customer expectations, and global quality priorities.
  • Quantify the value of quality technology programs, including improvements in quality, compliance, productivity, cost, speed, and user experience.
  • Translate emerging quality technology needs into business cases, user and functional requirements, governance expectations, and execution plans.

Regulated Technology Leadership & Technical Oversight

  • Provide quality technology leadership and design-authority input for acquisition integration, new site adoption, digital transformation and enterprise programs that impact regulated quality processes.
  • Ensure requirements, intended use, regulatory risk, validation strategy, data integrity, electronic records, change control, and sustainment needs are defined and maintained through the system lifecycle.
  • Provide technical leadership across regulatory requirements, risk management, validation, CSA, data integrity, electronic records, automated inspection, and AI/ML.
  • Support audit readiness for enterprise quality systems and regulated technologies, including validation, training records, electronic records, data integrity, and QMS governance.

Innovation & Digital Quality Enablement

  •        Partner with IT and business leaders to evaluate, implement, and scale digital quality solutions that improve speed, control, visibility, compliance, user adoption, and enterprise value.
  •        Drive adoption of data-driven, AI-enabled, and risk-based CSA approaches that modernize regulated quality technology practices.
  • Represent Integer in external industry advisory groups and meetings, where appropriate, to help shape and learn from evolving best practices in regulated quality technology

Training, Adoption & Enterprise Enablement

  • Partner with Global Process Owners, subject matter experts, IT, and Training to define practical training, coaching, and adoption approaches for enterprise quality technologies.
  • Ensure deployments include role-based training, user guidance, adoption support, and sustainment expectations.
  • Promote solutions that are simple, scalable, user-focused, and designed to reduce friction for frontline associates and business users.

Team Leadership & Talent Development

  • Lead, coach, and develop a team responsible for digital quality enablement, GxP training governance, software assurance, and enterprise platform support.
  • Establish clear priorities, objectives, communication routines, and decision pathways that align team efforts to business priorities, program milestones, site needs, and individual development plans.
  • Remove barriers, escalate risks, and coordinate cross-functional support when issues require decisions across Quality, IT, Operations, Engineering, Regulatory, or site leadership.
  • Build a culture of accountability, teamwork, inclusion, continuous improvement, and mutual trust.

Governance, Compliance & Quality Culture

  • Ensure quality technology solutions are effective and comply with company policies, QMS requirements, environmental requirements, FDA regulations, global standards, and applicable regulatory expectations while supporting ongoing audit readiness.
  • Champion accountability, innovation, continuous improvement, and the mindset of “I own Quality.”

Education & Experience:

Minimum Education:

  • Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related technical field required.

Minimum Experience:

  • 8+ years of experience in Quality, IT, Operations, or related functions within an FDA regulated environment.
  • 3+ years of supervisory or leadership experience.
  • You have experience implementing, validating, governing, or sustaining technologies used in FDA-regulated environments, including QMS, MES, LMS, and related enterprise platforms.
  • You can demonstrate ability to drive adoption of new technology by balancing compliance, user experience, business value, and operational practicality.

Knowledge & Skills You Need:

  • 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.

Salary Range: $128,250.00 - $188,100.00





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. 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) plan 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.

Apply once. Then go straight to the hiring manager.

After you apply, unlock the direct contact details of the people who actually make the call. A quick follow-up makes you 5x more likely to land an interview.

MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
Unlocked after you apply
·

Quality Manager Related jobs

Other jobs at Integer Holdings Corporation

Premium

Reach out to the hiring manager directly.

Gain access to the contact details of the hiring managers who actually decide, and reach out to network with them directly. That, plus more when you upgrade:

  • Full match report with fit score and gaps
  • Career diagnostics on how recruiters read you
  • Curated company matches and warm intros
  • 48h early access to new roles

Cancel anytime.