Senior Quality Manager, Technology

Integer Holdings Corporation; Plano (TX); On-site; USD 128,000 - 188,000; Full time

Benefits offered by this job

Medical benefits

401(k) matching

Parental leave

Paid time off

Adoption benefits

Job summary

Integer Holdings Corporation seeks a seasoned leader to drive digital quality enablement across FDA-regulated environments. You will shape QMS technology strategy, ensure validation and data integrity, and guide regulatory compliance across multiple sites and integrations.

Collaborating with IT, Operations, Regulatory, and site leadership, you will establish governance, optimise processes, and promote a culture of continuous improvement while delivering measurable business value.

Qualifications

• Bachelor’s degree required in Engineering, Life Sciences, Information Systems, or related field.
• 8+ years of experience in Quality, IT, Operations, or related FDA-regulated environments.
• 3+ years of supervisory or leadership experience.
• Experience implementing, validating, governing, or sustaining technologies used in FDA-regulated environments (QMS, MES, LMS, and related platforms).
• Ability to drive adoption of new technology while balancing compliance, user experience, and business value.
• Knowledge of EU MDR, ISO 13485, ISO 9001, GMP, 21 CFR 820, and FDA CSA guidance.

Responsibilities

• Define QMS technology strategy, annual priorities, roadmaps, and measurable objectives.
• Align stakeholders on standard, scalable technology solutions supporting business strategy and quality priorities.
• Provide quality technology leadership for acquisition integration, new site adoption, and digital transformation at enterprise scale.
• Ensure requirements, regulatory risk, validation strategy, data integrity, electronic records, change control, and sustainment through the lifecycle.
• Support audit readiness for enterprise quality systems and regulated technologies, including validation and governance.

Skills

Cross-functional leadership

Regulatory knowledge

Quality systems

CSV/CSA

Data integrity

Lifecycle governance

Education

Bachelor's degree in Engineering, Life Sciences, Information Systems, or related field

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.CustomerWe focus on our customers’ successInnovationWe create better solutionsCollaborationWe create success togetherInclusionWe always interact with others respectfullyCandorWe are open and honest with one anotherIntegrityWe do the right things and do things rightAccountabilities & Responsibilities:Strategy, Roadmap & Value AccelerationPartner 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 OversightProvide 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 technologyTraining, Adoption & Enterprise EnablementPartner 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 DevelopmentLead, 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 CultureEnsure 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 - $188,100.00Our 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.