Philips Supplier Quality Engineer in Unknown Location, Hong Kong
The Director of Q&R for Personal Health Solutions is required to be a this hands on, highly participative manager, responsible for leadership and direction of Quality Assurance and Regulatory Affairs organization. The Director is responsible for the promotion of quality awareness and continuous improvement throughout the organization while developing, implementing, maintaining and improving the quality system and ensuring compliance with all applicable regulatory requirements and all applicable Philips Healthcare and Philips Population Health Management policies, initiatives and procedures.
• Identify and implement best practices to improve efficiency and maintain compliance and lead the function in continuous process improvement.
• Ensures that regulatory strategies adequately support product development activities and result in the timely approval of new and revised products; thus, must have good knowledge of US regulation and general knowledge of European Regulations, including the Medical Device Directive and Health Canada Regulations.
• Represent the business during any audit processes, internal or external. Drive compliance across all functions of the business and ensure preparedness for any audits. Take action on any audit findings, to reinforce compliance or remedial action on any unsatisfactory findings.
• Willingness to be directly involved in all tactical and administrative aspects of the position.
• Works with Corporate Quality Assurance and other quality assurance and regulatory leaders across the corporation to identify and implement best practices.
• Responsible for ensuring that the overall business unit processes and initiatives are compliant with all applicable external standards and regulatory requirements.
• Implements appropriate activities to ensure regulatory compliance and adherence to the quality system.
• Maintains productive working relationships with external regulatory bodies.
• Ensures that quality systems functions such as complaint handling, corrective and preventive action, and the internal audit program are effective and compliant.
• Ensures that business unit functions are adequately supported with appropriate quality assurance and regulatory resources.
• Monitors external changes to the regulatory environment to ensure the continued compliance of the quality system.
Philips Personal Health Solutions is an entrepreneurial business in Philips Population Health Management. Philips Personal Health Solutions combines leading technology and data-driven population management with clinical expertise and a proven programmatic approach. The new care models this approach provides help health care systems and clinicians meet the demands of the evolving, pay-for-value focused healthcare landscape. Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
We are looking for
• Bachelor's degree (Science, Engineering or similar technical discipline) required
• Master's degree in business, management or quality strongly preferred
• Minimum 10 years of progressive management experience in a responsible quality assurance/regulatory affairs role.
• Experience in quality systems associated with the development, manufacture and support of hardware and software medical products and applications.
• Experience in validation of software systems and systems security and control.
• Experience working in disciplined regulated industry/medical device environment in the application of automated technology.
• Experience with computerized systems implementations, comprised of multiple application types, in a regulated environment.
• Demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives.
• Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
• Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
• General understanding of world-wide standards and regulations
• Experience in direct interactions with world-wide regulatory authorities a plus, specifically Canada.
• Proven leadership in formulating and implementing strategies to ensure product quality, compliance with US and internatioinal regulations.
• Strong communication skills and a highly collaborative style
• Achievement oriented and customer focused
Call to Action / Contact
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Ready to start improving lives by putting your personal skills & passions to work?
Find out more info about Philips at www.philips.com/na/careers
Philips is an equal opportunity employer