Senior Quality Manager, Technology

Integer Holdings Corporation

22h•$128,250 - $188,100

About The Position

This role is responsible for defining the QMS technology strategy, annual priorities, roadmaps, and measurable objectives in partnership with Global Quality Systems leadership. The position involves aligning stakeholders on standard, scalable technology solutions that support business strategy, customer expectations, and global quality priorities. A key aspect is quantifying the value of quality technology programs, including improvements in quality, compliance, productivity, cost, speed, and user experience. The role also translates emerging quality technology needs into business cases, user and functional requirements, governance expectations, and execution plans. Additionally, it provides quality technology leadership and design-authority input for acquisition integration, new site adoption, digital transformation, and enterprise programs impacting regulated quality processes. The Senior Quality Manager ensures requirements, intended use, regulatory risk, validation strategy, data integrity, electronic records, change control, and sustainment needs are defined and maintained throughout the system lifecycle. They provide technical leadership across regulatory requirements, risk management, validation, CSA, data integrity, electronic records, automated inspection, and AI/ML. Support for audit readiness for enterprise quality systems and regulated technologies, including validation, training records, electronic records, data integrity, and QMS governance, is also a responsibility. The role partners with IT and business leaders to evaluate, implement, and scale digital quality solutions, driving adoption of data-driven, AI-enabled, and risk-based CSA approaches. Representation in external industry advisory groups is also part of the role. Furthermore, the position involves defining practical training, coaching, and adoption approaches for enterprise quality technologies, ensuring deployments include role-based training, user guidance, adoption support, and sustainment expectations. The Senior Quality Manager leads, coaches, and develops a team responsible for digital quality enablement, GxP training governance, software assurance, and enterprise platform support, establishing clear priorities and objectives. They remove barriers, escalate risks, and coordinate cross-functional support, while building a culture of accountability, teamwork, inclusion, continuous improvement, and mutual trust. Finally, the role ensures quality technology solutions are effective and comply with company policies, QMS requirements, environmental requirements, FDA regulations, global standards, and applicable regulatory expectations, championing accountability, innovation, continuous improvement, and the mindset of “I own Quality.”

Requirements

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.
Demonstrated ability to drive adoption of new technology by balancing compliance, user experience, business value, and operational practicality.
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.

Responsibilities

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.
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.
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.
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.
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.
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.”