Job Description

• 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.
• nalyze 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.
• cts in full compliance to all applicable regulatory requirements and Philips Quality policies.

• 4+ years' experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a regulated industry.
• Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 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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