Senior Quality Manager, Technology

🔥 4 hours ago

🇺🇸 United States – Remote

💵 $128.3k - $188.1k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Integer Holdings Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1970

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 Post-IPO Debt on 2023-01

Healthcare • Manufacturing • Healthcare Insurance

Integer Holdings Corporation is a leading provider of advanced medical device outsourcing services. With a rich history of 80 years, Integer specializes in the design, development, and manufacturing of medical devices and components. It serves major global OEMs by offering a wide range of products such as finished device systems, Class III Medical Devices, and components for cardiac rhythm management, neuromodulation, and vascular health markets. Integer is renowned for its manufacturing excellence, innovation, and commitment to enhancing patient lives through high-quality medical solutions. The company operates globally, providing unique design expertise, comprehensive product development, and strategic partnerships in the medical device industry.

📋 Description

• Partner with Global Quality Systems leadership to define QMS technology strategy, annual priorities, roadmaps, and measurable objectives • Align stakeholders on standard, scalable technology solutions supporting business strategy, customer expectations, and global quality priorities • Quantify the value of quality technology programs across 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 affecting regulated quality processes • Ensure requirements, intended use, regulatory risk, validation strategy, data integrity, electronic records, change control, and sustainment needs are maintained through system lifecycles • 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 • Evaluate, implement, and scale digital quality solutions with IT and business leaders • Drive adoption of data-driven, AI-enabled, and risk-based CSA approaches • Represent Integer in external industry advisory groups and meetings where appropriate • Define training, coaching, adoption, and sustainment approaches for enterprise quality technologies • Lead, coach, and develop a team responsible for digital quality enablement, GxP training governance, software assurance, and enterprise platform support • Establish priorities, objectives, communication routines, and decision pathways aligned with business priorities and development plans • Remove barriers, escalate risks, and coordinate cross-functional support across Quality, IT, Operations, Engineering, Regulatory, and site leadership • Ensure quality technology solutions comply with company policies, QMS requirements, environmental requirements, FDA regulations, global standards, and applicable regulatory expectations • Champion accountability, innovation, continuous improvement, and the “I own Quality” mindset

🎯 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 • 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 • 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

🏖️ Benefits

• Cash-based incentive program • Medical insurance • Dental insurance • Vision insurance • Disability insurance • Life insurance • Adoption benefits • Parental leave available after one year • Optional supplemental life insurance • Optional critical illness insurance • Optional hospital indemnity insurance • Optional accident insurance • 401(k) plan with company matching contributions • 80 hours (10 days) of company designated holidays per year • Annual allotment of paid time off