Responsibilities :
- Lead all quality elements of Design Controls and product DHF for design projects.
- Drive Quality norms associated with design engineering projects.
- Support integration of Risk Management processes throughout the product lifecycle from initial development through post market surveillance in accordance with Client processes and global standards.
- Lead Quality Plan initiatives associated with Risk Management and Quality System integration.
- Support integration of post market surveillance processes into Design Controls and Sustaining initiatives through analysis of field performance, identification of trends and risks, and actions.
- To eliminate or mitigate adverse post market issues.
- Support the Regulatory Affairs department for submissions and respond to submission questions.
- Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement initiatives.
- Analyze situations / data using engineering principles and collaboration to identify gaps between project work and QMS.
- Quality responsibility for transfer of new products and sustaining projects to manufacturing and operations quality and supplier quality teams.
- Support internal and external audits.
- Acts in full compliance to all applicable regulatory requirements and Philips Quality policies.
Requirements :
- years' experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a regulated industry.
- Experience with ISO , CR , ISO , EU MDR, IEC -, IEC , and IEC standards.
- Strong understanding of design quality tools, methods, and activities.
- Strong statistical background in verification, validation, hypothesis testing, sampling, multifactor analyses and measurement system analyses.
- Demonstrated expertise in managing complex projects.
- Excellent customer service and interpersonal communication skills, experience leading presentations in front of peers and managers.
- Hands-on problem solver that drives solutions within teams.
- Excellent teamwork skills including influencing and building rapport with internal customers and stakeholders.
- Demonstrated track record of completing projects on-time that meet all objectives.
- Local candidates are preferred. Relocation assistance available.
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