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Job description
Stryker is hiring a Manager, Quality Management Systems for our Joint Replacement division in Mahwah, New Jersey to lead a multi-functional team focused on the implementation of standards & regulations within the QMS and management of master data within enterprise systems. Together with the team, ensure overall compliance with applicable global regulatory and statutory requirements. Foster a culture of growth and development for direct reports while achieving business goals and objectives through the contributions and results of the team.
Workplace Flexibility: Hybrid Position: This role requires a minimum of two days per week onsite at our Mahwah, NJ location where candidates must be within a commutable distance or open to relocation.
What you will do:
Lead and manage a team, including defining roles, planning for future needs, counseling on performance, and contributing to decisions on employee compensation and changes.
Oversee the Standards & Compliance and Enterprise Systems teams, ensuring compliance with all applicable regulatory and statutory requirements.
Empower teams to drive divisional processes, ensuring effective implementation of standards and regulatory requirements within the quality management system.
Provide guidance on managing master data within enterprise systems to maintain data integrity and support operational excellence.
Collaborate with senior leadership to establish, communicate, and execute strategies aligned with business objectives and goals.
Set team goals and objectives, manage performance, deliver coaching, and conduct periodic performance reviews to drive individual and team success.
Maintain expert-level knowledge of federal and international regulations related to regulatory actions to ensure compliance and provide informed guidance.
Continuously evaluate and align divisional processes with corporate policies, guidance, and procedures to support organizational objectives.
What you will need
Required:
Bachelor's degree or higher with a minimum of 8 years of experience in a regulated industry with a minimum of 2 years’ experience as a people manager, leading quality or engineering teams.
Experience working with standards and regulations such as QSR (21 CFR Part 820), Medical Device Reporting (21 CFR Part 806), Enforcement Policy (21 CFR Part 7), ISO 13485, European Medical Device Directive, or Canadian Medical Device Regulations (CMDR).
Preferred
Bachelor degree in a Science related discipline
Over 4 years of experience in regulatory compliance within medical devices, pharmaceuticals, or other regulated industries, including managing, developing, and implementing processes and procedures.
Proven ability to lead and collaborate with diverse teams, including multi-national groups, ensuring compliance with regulatory requirements and internal processes.
Skilled in managing complex projects, prioritizing and delegating tasks effectively in deadline-driven environments.
Accomplished in achieving objectives with minimal supervision while guiding individual contributors to success.
Proficient in Microsoft Office Suite applications, including Outlook, Word, Excel, and PowerPoint.