Senior Quality Manager, Technology

🕒 Setembro 1

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $128.250 - $188.100 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Integer Holdings Corporation

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1970

🏥 Saúde

🏭 Manufatura

⚕️ Seguro de Saúde

💰 Post-IPO Debt em 2023-01

Healthcare • Manufacturing • Healthcare Insurance

A Integer Holdings Corporation é uma fornecedora líder em serviços terceirizados de dispositivos médicos avançados. Com uma rica história de 80 anos, a Integer se especializa no design, desenvolvimento e fabricação de dispositivos médicos e componentes. Atende grandes OEMs globais, oferecendo uma ampla gama de produtos, como sistemas de dispositivos acabados, Dispositivos Médicos Classe III, e componentes para os mercados de gestão de ritmo cardíaco, neuromodulação e saúde vascular. A Integer é renomada por sua excelência em fabricação, inovação e comprometimento em melhorar a vida dos pacientes através de soluções médicas de alta qualidade. A empresa opera globalmente, fornecendo expertise única em design, desenvolvimento abrangente de produtos e parcerias estratégicas na indústria de dispositivos médicos.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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