Stryker Senior Manager, Quality Systems in Flower Mound, Texas
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.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com