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Senior Director of Quality (Health Informatics)

PhilipsJobsNA Philips

Philips is a leading health tech company, improving people’s health and enabling better outcomes across the health continuum—from healthy living and prevention to diagnosis, treatment, and home care.

Job Title
Senior Director of Quality (Health Informatics)

Job Description

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees may request a reasonable accommodation. Montana employees are currently excluded from this requirement at this time.

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

Provide strategic direction and leadership regarding all aspects of quality to the EMR/CM business and quality teams, and associated sites.

The leader is a driving force in making EMR/CM an industry-leading organization through improved customer experience, operational excellence, and proactive regulatory compliance for Class I and II informatics-based software medical devices, including modules, platforms and systems. This position is accountable for end-to-end quality across the product life cycle including new product introduction, sustaining & improvement engineering, risk management, post market surveillance, acquisitions and integrations, management of the Quality Management System (QMS) and quality key performance indicators assuring business quality & compliance. This leader will work closely with global manufacturing and supplier quality teams (matrix organization), customer service, procurement, and business focused distribution centers.

You are responsible for

  • 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 EMR/CM cross-functional business leadership team to effectively improve 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 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, services and systems requirements meet global quality and regulatory requirements throughout the product lifecycle.
  • Develop and drive Quality HW and SW systems engineering capability driving the CC Cluster.
  • Work with SW COE, Security COE to ensure end to end integrity. Drive DFSS, DFR for SW, HW and risk management at both product and systems level.
  • Lead, collaborate and partner with site quality leaders, business management teams, Philips Central teams, markets 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 EMR/CM 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 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-own the career development plans of your team members.

You are part of

A team of customer-focused, collaborative, and results-driven quality leaders dedicated to adding value and quality excellence throughout the product life cycle. Inspired by the Philips Purpose, we strive to delight our customers and deliver our brand promise with safe, reliable and effective products and services. We support and encourage stretching ourselves to grow and develop our skills and capabilities that leads to full careers and strong teams.

The position reports solid line to the Head of Quality for the Connected Care Cluster and dotted line to the EMR/CM Business Leader. It is a key member of the Connected Care Quality Management Team.

To succeed in this role, you’ll need a customer-first attitude and the following

  • Bachelor’s degree (Science, Engineering or similar technical discipline) required, Master’s degree in business, management or quality strongly preferred
  • Minimum 15 years global medical device industry experience with significant class I/II informatics-based software products, platforms and systems experience demonstrating progressive leadership
  • Strong leadership skills and the ability to function well within a matrix organization
  • Leadership experience in various aspects of Quality, such as design quality, quality systems, post market surveillance and internal / external audit representation
  • Experience in leading a team in establishing and implementing Quality strategy, Quality systems, etc for multi-site business in a large multi-national company
  • Relevant training, experience and certification (ASQ Quality Manager, Auditor, Six Sigma, DFSS, reliability engineering), Continuous Improvement methodologies and Quality tools such as Lean, Six Sigma, 5 Why’s, Fishbone, etc.
  • 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, 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 up to 25%

In return, we offer you

At Philips, we are driven by our mission to improve the lives of 2 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. If you are interested in driving action to improve patients’ lives so they get home healthier and faster and stay there longer, then this position is poised to help you achieve that goal.

Our benefits can be found here: https://www.careers.philips.com/na/en/total-rewards-at-philips .

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it’s like working at Philips , read stories from our employee blog , find information about our recruitment process and answers to some frequently asked questions .

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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 888-367-7223, option 5, for assistance.
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Senior Director of Quality (Health Informatics)

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Philips

Philips is a leading health tech company, improving people’s health and enabling better outcomes across the health continuum—from healthy living and prevention to diagnosis, treatment, and home care.

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