Director of Quality for Clinical Informatics - Best, Nederland - Philips International

Beschrijving

Director of Quality for Clinical Informatics page is loaded

Director of Quality for Clinical Informatics

Apply locations Best time type Full time posted on Posted 6 Days Ago job requisition id

Job Title

Director of Quality for Clinical Informatics

Job Description

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.

• Lead, collaborate, and partner with site quality leaders, business management teams, Philips Central teams, regions, and functions on strategic initiatives and transformations.

• 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%

About Philips
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.

• Learn more about our business .

• Discover our rich and exciting history .

• Learn more about our purpose . If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here . #LI-EU
#LI-Hybrid

Similar Jobs (1) Sr. Regulatory Affairs Manager (Clinical Informatics)

locations Best time type Full time posted on Posted 30+ Days Ago

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people's health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

We're committed to building a diverse and inclusive workplace culture where people feel heard, valued and connected. Because we know the possibilities are unlimited when people feel empowered to grow and succeed together.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members , marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact , option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran

#J-18808-Ljbffr