Philips
Program Coordinator- Quality
Program Coordinator- Quality
Key Responsibilities: As a Program Coordinator, you will play a pivotal role in ensuring the efficiency and effectiveness of our correction and removal processes. Your responsibilities will include:
Ensuring that processes for specifying and executing corrections and removals are robust, aligning with other critical processes such as risk management and CAPA (Corrective and Preventive Actions), and meeting the expectations of key stakeholders.
Providing oversight of correction and removal activities across Philips Top Management, ensuring adherence to protocols and timely decision-making.
Facilitating the availability of tools necessary for the efficient and effective implementation of correction and removal programs.
Monitoring and coordinating various subsystems involved in the correction and removal process, ensuring timely input and decisions from the Correction & Removal Review Board (CRRB).
Preparation and management of key documents including Health Hazard Evaluations, Correction and Removal documents, Regulatory Reports, Periodic Update Reports, Termination Requests, and various internal reports.
Continuously tracking field actions and providing ongoing progress updates to key business partners, the Field Corrective Action (FCO) team, and Regulatory Operations teams as required.
Providing actionable insights through comprehensive C&R analytics across the organization and management.
Required Competencies:
Bachelor's degree preferably in Engineering, Science, healthcare, nursing, or a related technical field with a minimum of 3 years of relevant experience in program management.
Hands-on experience in Microsoft Excel and data management.
Strong analytical skills with attention to detail.
Capability in process improvement, demonstrating the ability to address complex issues creatively and effectively.
Excellent written and verbal communication skills in English.
Ability to thrive in a demanding work environment.
Proficient understanding of global medical device regulations and standards, including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169 (is advantageous).