▷ Apply Now Senior Staff Quality Systems Engineer
3 days ago
Position Summary
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.
Serves as an active member of hub and spoke teams (led by GPOs) to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global QMS.
Key Areas of Responsibility
1. 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).
2. Ensure optimum state of QMS for current and future business needs.
3. Identify and deliver strategic and futuristic improvements and inputs into the quality planning process.
4. Drive development and/or modification of Stryker's QMS.
5. Assess and quantify requirements for QMS requirements to optimize structure.
6. Ensure GMP and GDP compliance within Quality organization.
7. Provide guidance for the development, maintenance, and improvement to policies and procedures to increase the efficiency and effectiveness of the QMS.
8. Ensure development and delivery of training for QMS areas of expertise.
9. Drive development of best-in-class practices and benchmark against industry leaders and regulatory requirements.
10. Liaise with notified bodies to manage certification changes.
11. Ensure QMS reflects actual activities, business needs and supports NPD requirements.
12. Manage QMS activities to support achievement of project milestones.
13. Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects.
14. Owner of QMS business processes and understanding of IS system support requirements.
15. Represent expertise during internal and external quality system audits.
16. Strong knowledge of system integration.
17. Assess and approve IS change control assessment and approval.
Additional Responsibilities
1. Coordinates input, feedback, and represents their division's needs.
2. Accountable for local process and training implementation.
3. Updates the GPO and/or PMO on divisional deliverables and progress.
4. Ensures the global initiatives in their area are communicated and understood by divisional stakeholders.
5. Serves as the voice for their division in the process area.
6. Travels to hub and spoke meetings.
7. Engages in meetings, surveys, information gathering and decisions.
8. Delivers against agreed project deadlines.
9. Communicates to leadership and stakeholders throughout levels at their division/site.
Education / Work Experience
1. BS in a science, engineering, business or related discipline.
2. Minimum of 7 years experience in manufacturing environment or equivalent preferred.
3. Experience in regulated environment and interaction with regulatory agencies required.
4. Prior divisional or site experience desired.
Knowledge / Competencies
1. Thorough knowledge and understanding of US and International Medical Device Regulations.
2. Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
3. Strong communication, project management and influencing skills.
4. Ability to plan, organize, and implement multiple concurrent tasks.
5. 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.
6. Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
7. Demonstrated ability to work in cross-functional team environments.
8. Builds strong relationships by fostering open communication, respect and trust.
9. Act with a customer service/stakeholder-focused approach.
10. Leverages excellent interpersonal skills to achieve desired outcomes.
11. Present as a change agent by adopting a continuous improvement orientation.
12. Act as the voice of Quality in cross-functional teams, ensuring appropriate outcomes.
13. Computer literacy.
14. Some travel may be required.
Additional Qualifications
1. Subject matter expert for the regulatory and Stryker-business requirements of their area of ownership.
2. Effective communicator and consensus-builder.
3. Proven ability to implement large-scale projects on a broad scale.
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