Senior Quality Manager, Technology

Integer Holdings Corporation; Northern (KY); Hybrid; USD 128,000 - 188,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) with matching contributions

Paid holidays and time off

Job summary

Integer Holdings Corporation seeks a senior leader to guide digital quality enablement across regulated environments in the United States. You will define technology strategy for QMS, CSA, and related platforms, align stakeholders, and drive value through data-driven decisions.

You will build and lead a global team, ensure compliance with FDA and ISO standards, and partner with IT and Operations to accelerate digital transformation while maintaining audit readiness.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Information Systems, or related field.
• 8+ years in Quality, IT, Operations in FDA-regulated environment.
• 3+ years of supervisory or leadership experience.
• Experience implementing, validating, governing, or sustaining technologies in FDA-regulated environments (QMS/MES/LMS).

Responsibilities

• Define QMS technology strategy, priorities, roadmaps and objectives.
• Align stakeholders on scalable technology solutions supporting strategy and quality.
• Quantify value of quality tech programs including improvements in quality and compliance.
• Translate needs into business cases, requirements, governance and execution plans.
• Provide technology leadership for acquisitions, new site adoption and digital programs.

Skills

Regulated quality tech

CSV/CSA

Electronic records

Data integrity

Lifecycle governance

Education

Bachelor's degree in Engineering/Life Sciences/IS

Tools

QMS

MES

LMS

Enterprise platforms

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, accelerate 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

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

Benefits

• 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.

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical® and Lake Region Medical®.

Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination.

Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active‑duties wartime veteran, campaign badge veteran, referred to collectively as \"Protected Veterans\". It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment. Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons.

For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.