Senior Manager, Quality Systems in Fremont, CA at Stryker Corporation

Date Posted: 9/28/2018

Job Snapshot

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

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team