Head of Q&R
Head of Q&R
In this role you will be required to be a resourceful and a strategic thinker who will work to provide results-oriented leadership and creativity to lead an effective and hardworking Q&R organization while teaming closely with business and business categories leaders to maintain a robust and efficient Quality Management System. The Quality Leader will work closely with business partners and various business group Q&R leaders to drive standardization of key processes including product quality initiatives
You are responsible for
- Leading all aspects of business group related Quality functions across Philips including new product design quality, post market surveillance and product safety teams and general quality compliance functions to support compliance to business related Q&R quality management systems.
- Working in close conjunction with Regulatory Affairs Capability leader across the business and Q&R capability and represents RA strategy and decisions at business Management team. Will be responsible for setting budget for Q&R for the business.
- Creating and deploying Quality strategy for business management and quality systems to ensure consistent, standardized execution of Philips Excellence Process Framework processes.
- Leading Quality management representatives for all key regulatory agencies for product safety and quality (e.g: US FDA). Develop and maintain an effective working relationship with US FDA, EU N.B. and other international regulatory bodies & competent authorities. Ensures that the organization's products meet customer requirements and applicable quality standards.
- Working closely with the Operation teams to ensure all facilities (e.g: manufacturing, business unit sites and distribution etc.) consistently operate in a state of compliance and inspection readiness;
- Actively ensuring all products, services and systems offered to customers and consumers consistently meet regulatory agency requirement as required. Ensures all responsible sites and are fully aligning with local and international standards such as 21 CFR Part 820, ISO 13485, IEC 62304, MDD/CE and other relevant regulatory/global standards suitable for product design and manufacturing contained within such sites.
- Working closely with central Philips and Business task forces to implement EU Medical Device Regulation (MDR) to ensure no business revenue impact.
- Establishing a strong core Q&R team while driving common goals and objectives to result in improved customer experience, operational excellence & dedicated regulatory compliance. Representing business needs with customer as appropriate to provide updates on product related matters.
- Attracting, developing, engaging and retaining team members to ensure strong and talent succession in quality & regulatory organizations. Driving ambition towards Philip's people strategy, act as a coach and co-own the career development plans of team members.
- Partnering with business Operations entities to drive continuous improvement and premier manufacturing strategies. Act as an enthusiastic team member on ensuring Philips Operations strategy is successful and sustainable.
- Driving quality planning and strategy for mature product transfers from site to site or between Philips and 3rd party. When applicable ensuring any product integration of newly acquired products, assets, and organizations into business unit and manufacturing sites are well run to ensure no quality impact to business and Philips.
- Providing leadership direction to all contributing and accountable partner functions in maintaining the highest levels of design product quality and compliance and drives standardized quality Key Performance Indicators (KPIs) rhythm across all design/business sites as part of daily management.
- Partnering with Business leadership, R&D, Supply Chain, Engineering and Quality personnel to drive the resolution of customer driven issues including product complaints, and drives timely and effective solution to product design, manufacturing and supplier related quality issues.
- Establishing and implementing key metrics for monitoring system effectiveness to enable business units to make sound quality decisions across products, suppliers, customers, regulatory compliance and quality management systems.
- Ensuring that well-established product quality engineering is developed to support new product development support for business units and continuous improvements to current products and processes.
- Providing a forum for cross category businesses and operation quality & regulatory leaders to meet at defined frequency to ensure Philips and quality strategies are well implemented and to drive the best quality process practice across common areas that affect quality functions and strategies.
- When necessary, create written responses to FDA/Competent Authority observations to resolve in positive outcome for company.
To succeed in this role, you should have the following skills and experience
- Group level leadership and management experience in various aspects of Q&R (including internal and external representation on Q&R) AND especially in at least one quality functional domain (Product development, Operations etc.).
- Establishing Q&R strategy & oversight, Quality management system etc., at group/corporate level in a large multinational company.
- Minimum years of industry experience, in a highly regulated environment of Medical Devices, Automotive, Aerospace, etc., 8+ years of senior management group level experience. Time spent within an FDA and N.B. regulated medical device industry. Complimentary experience in R&D and Operations will be considered in addition to quality and regulatory experience. Proven ability to work as a senior/executive leader and be able to engage/influence the cross functional senior leadership team as needed.
- In-depth understanding and experience in design and manufacturing principles with working with medical devices.
- Leading and establishing multiple major quality management system processes and tools such as but not limited to CAPA program, and Complaint Management Process, and Management Controls in prior experience including systemic improvements across businesses and manufacturing sites.
- Working in remediation situations is required to ensure continuous improvements across various quality and non-quality type processes.
- Deep experience managing various FDA and Notified Body audits and inspections with favorable outcomes.
- Familiarity with business process classification framework including Industry practices and experience in continuous Improvement and transformation practices such as Lean/ Six Sigma, TCM, CTQ principles, DFX, Kaizen, Hoshins are highly preferred.
- Working with classified medical devices products and good understanding of combination devices. Some of the experience may include working within software development in a regulated environment and Service functions.
- Advocate and when necessary to lead continuous improvement across products and processes and ensures a continuous chain between product lifecycle E2E processes.
- Strong aptitude towards product and process risk management and how to institutionalize risk mitigation programs across products and manufacturing activities.
- Established leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrate ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
- Strong customer focus with doing it right the first time approach and be able to demonstrate high performance behavior of shared accountability, listening and learning, sense of urgency, trust and influence management, self-growth and grow others, and continuous improvement.
- Experience establishing change management behaviors and leading change through Q&R functions and key stake holders.
- Demonstrated affinity to visiting customers and driving customer focus discussions on products requiring customer feedback.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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