Principal Quality Systems Engineer - Global Steward - Management Controls
About the role:
Serve as a Principal Quality representative leading awareness, visibility, and communication of quality initiatives to support global quality goals, priorities, and the compliance of the BSC Global Quality System to applicable regulatory requirements and standards.
Designated as the BSC Quality System Management Control sub process steward and a subject matter expert for applicable QS regulations and standards that develops strategies for implementation of new / revised requirements. Develop quality and regulatory compliance strategies and provide input and coaching to maintain compliance and adapt the BSC Global Quality System to the continuously evolving external regulatory environment. Collaborate with Quality Management to recommend, design and implement functional process improvements.
Your responsibilities include:
- Establish and maintain Global BSC Management Control process to ensure compliance with applicable quality and regulatory requirements.
- Oversight of CAPA portfolio for Management Controls, including CAPA ownership.
- Develop and maintain process goals, objectives, metrics and/or methods, as required, for performance, continuous improvement, and monitoring.
- Collaborate with Quality management to recommend, design, and drive continuous improvement of the quality system that creates VIP.
- Lead Management Controls Community of Practice.
- Lead the preparation and logistics for quarterly Executive Committee Management Review (ECMR) and support Signal Review meetings.
- Lead or oversee quality projects of major magnitude and scope. Provide input to overall quality project portfolio and project priorities.
- Identify and maintain process training requirements.
- Support Corporate and site level internal and external audit as audit-facing SME. Provide guidance and expertise regarding audit strategies and approaches throughout BSC network.
- Maintain and enhances internal and external relationships in support of the Management Control process.
- Work cross-functionally in identifying and resolving technical and performance issues.
- Subject matter expert for applicable QS regulations and standards that develops strategies for implementation of new / revised requirements.
- Support Acquisition Leads and teams in the development of quality system integration strategies.
- Provide backup coverage of the Corporate Audit Support function and support external audits as a Quality Management System process subject matter expert.
- In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Other duties as necessary or required by the department.
What we’re looking for in you:
- Bachelor's degree in Science, Health, or Engineering plus > 8 years of related work experience in the medical device regulated industry
- Experience within Clinical, Design Controls, Risk Management and Quality Systems management for medical devices
- Experience in the development of external standards and participation in standards development organizations.
- Project management experience
- Strong presentation skills
- Strong communication skills
- Solid computer skills required including Excel, Word, and PowerPoint
- Potential global and US travel < 25%