As a Principal Quality System Specialist, you will primarily responsible for the strategic development of the quality management system in accordance with relevant regulatory requirements for medical devices. You will oversee and ensure that an effective and efficient quality management system is built and maintained while providing technical leadership on a local and global level. Under general direction, you'll also be responsible for leadership and directing of medium to high complexity projects as a QMS subject matter expert, most often with a focus on quality systems and associated technologies.
Essential Duties and Responsibilities:
Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, MDR and individual country requirements).
Provide guidance to identify and deliver strategic and futuristic improvements and inputs into the quality planning process.
Ensure optimum state of QMS for current and future business needs.
Drive development and / or modification of Stryker Spine’s QMS
Oversee identification and implementation of improvement opportunities to increase the efficiency and effectiveness of the QMS.
Liase with global and corporate partners to provide best-in-class global solutions and input into processes and systems.
Implement best-in-class practices and benchmark against industry leaders and regulatory requirements
Demonstrates subject matter expertise during internal and external audits for responsible processes and projects.
Strong knowledge of systems integration and inter-dependencies amongst the QMS and dependent technologies.
Provide direction for the overall QMS strategy.
Lead improvement processes, including executing and leading project primarily associated to quality systems and associated technologies.
Responsible for assembling project teams, assigning individual responsibilities, identifying resources needs and developing schedules to ensure timely project completion, as a QMS expert with or without formal project management resources.
Manage QMS activities to support achievement of project milestones and compliance initiatives.
Responsible for ensuring process owners are engaged in the development, maintenance and improvements of policies, procedures which they are accountable for.
Understand and contribute to the development and generation of IS compliance and validation documentation.
Owner of QMS business process(as) and / or systems, where applicable, and understanding of IS system support requirements.
Represent expertise during internal and external quality system audits.
Responsible for improving team performance by building team cohesiveness, leading and motivating, in order to facilitate cooperation, ensure project efficiency, and boost morale.
Drive development of best practices and bench-marking opportunities for the wider department, project team members and peer project managers.
What you need
Bachelor's degree; Emphasis in engineering, sciences, quality, or related discipline preferred
9+ years experience in the medical device industry or an equivalent regulated environment, with a focus on quality systems and / or regulatory affairs
Experience in regulated environment (medical devices preferred) and interaction with regulatory agencies required
You may also have
Quality and / or regulatory affairs certifications such as RAC, CQA, CQE, etc.
Thorough knowledge and understanding of US and international medical device regulations , including those of the EU and MDSAP regions
Strong knowledge of Quality Systems ( audits, validation, document control, record retention, training, etc.)
Demonstrated ability to develop and implement global strategies. Initiates, sponsors and implements changes with a demonstrated track record
Expert working knowledge of regulatory requirements, standards, and regulations with significant audit experience
Experience with the use and configuration of QMS-related software applications (PLM, ERP, LMS, etc.)
Knowledge of regulations, standards and industry practices associated with human and animal tissue is advantageous
Ability to plan, organize, and implement multiple concurrent tasks
Strong communication, project management and influencing skills
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.
Demonstrated ability to work in cross-functional team environments
Analystical and problem solving capabilities with ability to draw insights from data quickly and to define executable actions
Demonstrated ability to make timely and sound decisions through effective approaches for a choosing a course of action or developing appropriate solutions
Builds strong relationships by fostering open communication, respect and trust
Demonstrated ability to mentor, train, and develop direct and indirect team members
Leverages excellent interpersonal skills to achieve desired outcomes
Presents as a change agent by adopting a continuous improvement orientation
Act as the voice of Quality in cross-functional teams, ensuring appropriate outcomes
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.