Position Summary:
Responsible for strategic development of quality management systems in accordance with relevant regulatory requirements for medical devices. Ensure effective and efficient quality management systems are built and maintained, providing technical leadership to meet quality system regulations.
Serves as an active member of hub and spoke teams to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting the Global QMS.
Key Areas of Responsibility
* Ensure QMS compliance with internal and external regulatory requirements.
* Maintain optimum state of QMS for current and future business needs.
* Identify and deliver strategic improvements and inputs into the quality planning process.
* Develop and/or modify Stryker's QMS.
* Assess and quantify requirements for QMS optimization.
* Evaluate GMP and GDP compliance within Quality organization.
* Guide development, maintenance, and improvement of policies and procedures to increase efficiency and effectiveness of the QMS.
* Develop and deliver training for QMS areas of expertise.
* Benchmark best-in-class practices against industry leaders and regulatory requirements.
* Liaise with notified bodies to manage certification changes.
* Align QMS with actual activities, business needs, and support NPD requirements.
* Manage QMS activities to achieve project milestones.
* Provide direction for overall QMS strategy, leading improvement processes and executing projects.
* Own QMS business processes and understand IS system support requirements.
* Represent expertise during internal and external quality system audits.
* Demonstrate strong knowledge of system integration.
* Assess and approve IS change control assessment and approval.
Additional Responsibilities
* Coordinate input, feedback, and represent divisional needs.
* Accountable for local process and training implementation.
* Update GPO and/or PMO on divisional deliverables and progress.
* Communicate global initiatives in their area to divisional stakeholders.
* Serve as voice for their division in the process area.
* Travel to hub and spoke meetings.
* Engage in meetings, surveys, information gathering, and decisions.
* Deliver against agreed project deadlines.
* Communicate to leadership and stakeholders throughout levels at their division/site.
Education / Work Experience
* BS in a science, engineering, business, or related discipline.
* Minimum 7 years experience in manufacturing environment or equivalent preferred.
* Experience in regulated environments and interaction with regulatory agencies required.
* Prior divisional or site experience desired.
Knowledge / Competencies
* 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.
* Analytical and problem-solving capabilities with ability to draw insights from data quickly.
* Demonstrated ability to work in cross-functional team environments.
* Builds strong relationships by fostering open communication, respect, and trust.
* Act with customer service/stakeholder-focused approach.
* Levers excellent interpersonal skills to achieve desired outcomes.
* Presents as a change agent by adopting a continuous improvement orientation.
* Acknowledges the voice of Quality in cross-functional teams, ensuring appropriate outcomes.
* Computer literacy.
* Some travel may be required.
Additional Qualifications
* Subject matter expert for regulatory and Stryker-business requirements of their area of ownership.
* Effective communicator and consensus-builder.
* Proven ability to implement large-scale projects on a broad scale.