In this role, you have the opportunity to
Improve customer experience, proactive regulatory compliance and quality excellence. We are looking for a strong leader with excellent communication skills and deep content Quality knowledge. Global experience in the medical device space is required to support a growth business. While ensuring continuing compliance, your major focus will be on driving product quality.
You are responsible for
- Providing leadership and direction to the Quality and Regulatory Organization in support of the Magnetic Resonance (MR) Business Unit, including vertical supply entities and supported business units
- Acting as the management representative for all key regulatory agencies for product safety and quality (e.g.: US FDA, China FDA). Develop and maintain an effective working relationship with US FDA and otherinternational regulatory bodies.
- Acting as Site Q&R Custodian for multi-business group manufacturing sites, such as Best, Netherlands.
- Proactively ensuring all auditable facilities (e.g.: manufacturing, innovation, distribution etc.) consistently operate in a state of substantial compliance and inspection readiness; Proactively ensure all MR products, software, services and systems offered to customers and consumers consistently meet regulatory agency requirements.
- Establishing the vision and strategy for MR business management and quality systems, and practices to ensure consistent, standardized execution of Philips Excellence Process Framework processes.
- Establishing a strong core Q&R team and drives common goals and objectives to result in improved customer experience, operational excellence & proactive regulatory compliance.
- Attracting, developing, engaging and retaining your team members. You drive ambition towards our vision, act as a coach and co-own the career development plans of your team members.
- Provides direction to senior management and leadership teams in various areas, groups, and/or operations.
- Ensuring (in alignment with key stakeholders) the right Quality mindset in the Business and the realization of Business quality targets through proactive approach to Quality (e.g.: "design-in" Quality vs. inspection)
- Proactively ensuring compliance to all applicable regulations; Accountable for effective oversight on all operational processes End2End and throughout the product/software/service/systems lifecycle
- Leading and driving effective deployment of the Philips Excellence Process Framework and Quality Management Systems (PEPF and PEQS)
- Ensuring that all MR products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business.
- Participating with MR Leadership Team and other senior managers to establish strategic plans and objectives.
- Requires in-depth knowledge of the functional area, business strategies, and the company’s goals.
You are a part of
The Global MR Q&R team which is comprised of six business/site groups located across the world supporting MR system development, sub-level manufacturing, accessories, and final MR system manufacturing, installation and service. Direct reporting sites include Best Netherlands, Latham NY, Gainesville FL, Vantaa Finland, and Fitchburg, WI. Additional supporting activities are required with global Philips sites in Suzhou China and Bangalore India that support MR development and/or manufacturing. Additional engagement with the Philips Diagnostic Imaging Q&R competencies and Businesses is expected
To succeed in this role, you should have the following skills and experience
- Bachelor, Master’s Degree or PhD Degree in a technical discipline
- 12 plus years of regulated industry experience
- Preferred 10 years in a Medical Device manufacturing environment
- Must have senior leadership experience in various aspects of Q&R AND preferably in at least one operating process domain preferably operations Quality (Product development, Operations, Supply chain, etc.)
- Must be familiar with business process management framework including common industry practices
- Experience in change management is required.
- Relevant training, experience and certification in Continuous Improvement practices such as Lean/ Six Sigma highly preferred
- Business Acumen and strong Business Partnering Skills
- Effective communicator and relation builder/ networker
- Willing to travel up to 30 to 40% (mainly to China, US and Sweden)