Senior Quality Manager, Technology

integer; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Integer seeks a senior leader to guide digital quality enablement across regulated environments. You will define strategies for QMS technology, lead cross-functional teams, and drive governance, validation, and data integrity across enterprise platforms.

You will collaborate with IT, Regulatory, and operations to accelerate digital transformation while ensuring compliance with FDA regulations and global standards. This role emphasizes mentorship, accountability, and measurable business value.

Qualifications

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

Responsibilities

• Define QMS technology strategy, annual priorities, roadmaps, and measurable objectives.
• Align stakeholders on scalable technology solutions that support strategy, customer expectations, and global priorities.
• Quantify value of quality technology programs across quality, compliance, productivity, cost, speed, and user experience.
• Translate needs into business cases, user and functional requirements, governance expectations, and execution plans.
• Provide quality technology leadership and design-authority input for regulatory programs and site adoption.
• Ensure requirements, validation strategy, data integrity, electronic records, change control, and sustainment needs are defined and maintained.
• Drive adoption of data-driven CSA approaches to modernize regulated quality technology practices.
• Partner with Global Process Owners, IT, and Training to define practical training and adoption strategies for enterprise quality technologies.
• Build a culture of accountability, teamwork, inclusion, continuous improvement, and mutual trust.

Skills

Regulated quality tech

CSV/CSA

Data integrity

Lifecycle governance

Leadership

Education

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

Tools

QMS platforms

Electronic records systems

GxP IT tools

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, escalates 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 Pr