Senior Staff Quality System Specialist
Primarily responsible for the strategic development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee and ensure that an effective and efficient quality management system is built and maintained while providing technical leadership. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification. Leads hub and spoke teams to establish, implement, and maintain Global Regulatory and Quality processes, documents, and systems supporting our Global QMS.
Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
• Ensure optimum state of QMS for current and future business needs.
• Identify and deliver strategic and futuristic improvements and inputs into the quality planning process.
• Drive development and/or modification of Stryker's QMS.
• Manage and/or coordinate Management Review and Quality Planning Review and related forums.
• Assess and quantify requirements for QMS requirements to optimize structure.
• Ensure GMP and GDP compliance within Quality organization.
• Provide guidance for the development, maintenance, and improvement to policies and procedures to increase the efficiency and effectiveness of the QMS.
• Ensure development and delivery of training for QMS areas of expertise.
• Drive development of best-in-class practices and benchmark against industry leaders and regulatory requirements.
• Liaise with notified bodies to manage certification changes.
• Ensure QMS reflects actual activities, business needs and supports NPD requirements.
• Manage QMS activities to support achievement of project milestones.
• Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects.
• Understand and contribute to the development and generation of IS compliance and validation documentation.
• Owner of QMS business process(s) and understanding of IS system support requirements.
• Represent expertise during internal and external quality system audits.
• Strong knowledge of system integration.
• Assess and approve IS change control assessment and approval.
• 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.
• Bachelor's degree in a science, engineering, business or related discipline.
• Minimum of 7 years experience in manufacturing environment or equivalent preferred.
• Experience in regulated environment and interaction with regulatory agencies required.
• Prior cross-site/division experience desired.
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Strong communication, project management and influencing skills.
• Ability to plan, organize, and implement multiple concurrent tasks.
• Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
• Demonstrated ability to work in cross-functional team environments.
• Builds strong relationships by fostering open communication, respect and trust.
• Act with a customer service/stakeholder-focused approach.
• Leverages excellent interpersonal keys to achieve desired outcomes.
• Present as a change agent by adopting a continuous improvement orientation.
• Act as the voice of Quality in cross-functional teams, ensuring appropriate outcomes.
• Computer literacy.
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.
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