Senior Quality Manager, Technology

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with Global Quality Systems leadership to establish QMS technology strategy, yearly priorities, roadmaps, and measurable goals.

• Align stakeholders on standardized, scalable technology solutions that support business strategies, meet customer expectations, and adhere to global quality priorities.

• Assess the value of quality technology initiatives concerning quality, compliance, productivity, cost, speed, and user experience.

• Convert emerging quality technology demands into business cases, user and functional requirements, governance standards, and execution strategies.

• Provide leadership in quality technology and design authority for acquisition integration, new site implementation, digital transformation, and enterprise programs impacting regulated quality processes.

• Ensure that requirements, intended use, regulatory risks, validation strategies, data integrity, electronic records, change control, and sustainment needs are upheld throughout system lifecycles.

• Offer technical leadership in compliance with regulatory requirements, risk management, validation, CSA, data integrity, electronic records, automated inspection, and AI/ML.

• Facilitate audit preparedness for enterprise quality systems and regulated technologies.

• Assess, implement, and expand digital quality solutions in collaboration with IT and business leaders.

• Promote the adoption of data-driven, AI-enabled, and risk-based CSA methodologies.

• Represent Integer in external industry advisory groups and meetings as needed.

• Design training, coaching, adoption, and sustainment strategies for enterprise quality technologies.

• Lead, mentor, and develop a team tasked with digital quality enablement, GxP training governance, software assurance, and enterprise platform support.

• Set priorities, objectives, communication protocols, and decision-making pathways that align with business goals and development plans.

• Eliminate obstacles, escalate risks, and coordinate cross-functional support across Quality, IT, Operations, Engineering, Regulatory, and site leadership.

• Ensure that quality technology solutions are in compliance with company policies, QMS requirements, environmental standards, FDA regulations, global benchmarks, and relevant regulatory expectations.

• Advocate for accountability, innovation, continuous improvement, and the “I own Quality” philosophy.

⛳️ Requirements

• Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related technical discipline is required.

• Over 8 years of experience in Quality, IT, Operations, or related fields within an FDA-regulated environment.

• More than 3 years of supervisory or leadership experience.

• Proven experience in implementing, validating, governing, or maintaining technologies in FDA-regulated environments, including QMS, MES, LMS, and related enterprise platforms.

• Capability to drive the adoption of new technology while balancing compliance, user experience, business value, and operational feasibility.

• Comprehensive knowledge of regulated quality technology, including CSV/CSA, electronic records, data integrity, and lifecycle governance.

• Familiarity with 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 mindset focused on continuous improvement and a strong determination to overcome challenges in achieving objectives and delivering results.

• Ability to translate complex regulatory, technical, and business needs into actionable requirements, governance frameworks, and implementation plans.

• Strong cross-functional leadership abilities, concise communication, and influence skills across Quality, IT, Operations, Engineering, Regulatory, and site leadership.

• Proficient in building, leading, and developing global teams while effectively communicating 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 allocation of paid time off.