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Senior Manager, Quality Systems

Job Description

Key areas of responsibility: (Detailed Description)

  • Lead top-priority quality-system related outputs of Global strategic planning into program or project proposals that may be implemented by one or more Global Process Owners and form them into short and long-term deliverables.
  • Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, EU MDR, and individual country requirements).
  • Ensure optimum state of QMS for current and future business needs.
  • Provide guidance to identify and deliver strategic and futuristic improvements and inputs into the quality planning process.
  • Drive development and/or modification of Stryker's QMS.
  • Oversee and/or manage Management Review and Quality Planning Review and related forums.
  • Assess and quantify requirements for QMS requirements to optimize structure.
  • Oversee identification and implementation of improvement opportunities to increase the efficiency and effectiveness of the QMS.
  • Liaise with global and corporate partners to provide best-in-class global solutions and input into processes.
  • Ensure development and delivery of training for QMS areas of expertise.
  • Responsible for the development, maintenance, and improvement of policies and procedures.
  • Liaise with notified bodies to manage certification changes.
  • Ensure QMS reflects actual activities, business needs and supports Divisional, GQO, and Corporate requirements.
  • Manage QMS activities to support achievement of project milestones.
  • Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects.
  • Represent expertise during internal and external quality system audits.
  • Strong knowledge of system integration.
  • Ensures future needs are identified and planned
  • Negotiates the best path forward based on available time, resources and the voice of the customer
  • Explores creative options within Stryker and external to Stryker as well
  • Builds strong relationships with local QMS leaders in order to identify improvement opportunities for the Global QMS as it is implemented at a local level, then takes the initiative to develop and propose an improvement approach
  • Viewed as a global resource for QMS expertise and strategy
  • Takes initiative and responsibility to plan, coordinate and complete complex projects
  • Prepares and conducts training on Global QMS contents and structure to new acquisitions
  • Leads the implementation of overarching Global Quality Management System programs or projects as a result of:
    • Organizational change in Stryker entities or their relationships to one another
    • Enterprise Platform projects
    • Local or company-wide acquisitions that require an increase in the regulations/standards that the Global QMS covers
  • Serve as a Global Process Owner, for Global Quality System Processes (Future State QMS Mapping and Maturity Modeling) by:
    • Coordinates division and adjacent GPO input and represent collective needs.
    • Owns global documents and training materials.
    • Updates Global Governance, RA/QA Leadership and PMO on direction and progress.
    • Ensures global initiatives are communicated and understood by stakeholders.
    • Serves as the voice of the process area for Stryker.
    • Travels to and leads hub and spoke meetings.
    • Leads meetings, surveys, information-gathering and global decisions for geographically dispersed teams.
    • Delivers against agreed project deadlines and reconciles implemented sites.
    • Communicates to leadership and stakeholders at a global level.
    • Leads global cultural change

Education / work experience:

  • Bachelor s in Science or Engineering (or equivalent discipline) required
  • Master s degree (or equivalent) preferred
  • Minimum of 15 years experience in regulated environments/regulatory agency interactions required
  • Experience serving in a leadership capacity for quality system activities required
  • Experience leading cross-site/cross-division projects required

Knowledge / competencies:

  • Demonstrated ability to develop a strategic vision
  • Demonstrated ability to understand and navigate complex interpersonal and political issues.
  • Demonstrated versatility and a willingness to manage and lead a team through change and ambiguity.
  • Excellent interpersonal communication, collaborative teamwork, conflict management and negotiation skills.
  • Ability to present to, influence and build trusting relationships with executives.
  • Demonstrated ability to generate and explain complex opportunity analysis and value assessments accurately.
  • Demonstrated ability to mentor, train, and develop direct and indirect team members.
  • Expertise in quality system standards and regulations, including FDA 820, ISO 13485 and international standards, such as EU MDR, CMDCAS and Chinese GMPs
  • Demonstrated ability and expertise in leading quality assurance and systems as related to medical device design, production and distribution across multiple sites or entities
  • Strong ability to independently develop organizational relationships and trust
  • Excellent interpersonal and communication skills with senior management, including technical writing skills
  • Project management skills for projects spanning across different functional and international environments
  • Comfort and familiarity in presenting to leaders of business units
  • Ability to resolve conflict and disputes by addressing multiple viewpoints to develop a mutually satisfying outcome
  • Builds consensus to achieve common goals
  • Able to generate clear policies and directives, as well as detailed procedures and instructions, that add value to the business as well as meet quality requirements
  • Can perform at a high level without constant supervision
  • Excellent time management and organizational skills


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