Philips Director Quality Clinical Informatics 

Germany, Hesse 

12915048

Director of Quality for Clinical Informatics

In this role you will have the opportunity to provide strategic direction and leadership regarding all aspects of quality to the Clinical Informatics business and quality teams, and associated sites.
Your role:

• Lead a team of quality professionals to execute a single aligned quality strategy that is forward-looking and supports business growth, quality and regulatory compliance, improved product quality, and customer experience.

• Acts as a key influence and change agent on the CI cross-functional business leadership team to effectively improve safety, quality, and compliance outcomes.

• Act as the management representative for all key regulatory agencies for product safety and quality (e.g.: US FDA, EU MDR, TGA, MHLW, NMPA, etc.). Develop and maintain an effective working relationship with the US FDA and other international regulatory bodies/competent authorities.

• Proactively ensure all facilities and functions consistently operate in a state of compliance and inspection readiness; proactively ensure all products, software, platforms, services, and systems requirements meet global quality and regulatory requirements throughout the product lifecycle.

• Establish the vision and strategy to execute quality systems such that the QMS is compliant, effective, and efficient for the CI business. Assure consistent and standardized execution of Philips Excellence Process Framework processes while identifying and implementing best practices and driving continuous process improvement.

• Provide leadership to the quality team to drive common goals and objectives that improve patient safety, quality, customer experience, operational excellence & proactive regulatory compliance.

• Attract, develop, engage, and retain quality talent to establish a strong and capable team. Acts as a coach and co-owns the career development plans of your team members.

You're the right fit if:

• Bachelor's degree (science, engineering or similar technical discipline) required, Master's degree in business, management or quality is preferred
• Minimum 15 years global medical device industry with significant class 2 medical device experience demonstrating progressive leadership, and experience with software as a medical device (SAMD), software as a service (SaaS), artificial intelligence, and informatics is important.
• Strong leadership skills and the ability to function well within a matrix organization
• Leadership experience in various aspects of quality, such as design quality, risk management, quality systems, post market surveillance and internal / external audit representation
• Experience in leading a team in establishing and implementing quality strategy, quality systems, and the likes for multi-site business in a large global company
• Relevant training, experience and/or certification such as ASQ quality manager, Agile software methodology, Six Sigma, DFSS, reliability engineering, and Information Technology Infrastructure Library (ITIL)), continuous improvement methodologies and quality tools such as Lean, Six Sigma, 5 Why’s, Fishbone.
• Experience in quality system metrics through use of leading indicators to drive high performing systems and teams.
• Experience and knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO13485, ISO14971, ISO62304, EUMDR.
• Familiar with business process management frameworks including best industry practices related to QMS
• Experience in change management
• Business insight and strong business partnering skills
• Highly collaborative influencer who is an effective communicator and relation builder/ networker
• Proven ability to lead cross-functional, diverse teams with challenging goals
• Build and develop customer focused, results driven, strong and capable teams
• Willing to travel 10-20%

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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