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Director of Quality-Radiology Informatics - Hamel, United States - Philips
Description
Job TitleDirector of Quality-Radiology InformaticsJob DescriptionThe Director of Quality-Radiology Informatics (RI) will provide strategic leadership regarding all aspects of quality to the RI business, quality teams, and associated sites globally.
Exciting opportunity to be a driving force in making RI an industry-leading organization through improved customer experience, operational excellence, and proactive regulatory compliance for Class I and II Picture Archiving and Communication Systems (PACS) related medical devices, as well as non-medical devices.
Your role:
The Director of Quality-RI 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), customer service, procurement, and business focused distribution centers.
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 RI cross-functional business leadership team to effectively improve safety, quality, and compliance outcomes.
Acts 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.
Establish the vision and strategy to execute quality systems such that the QMS is compliant, effective, and efficient for the RI 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-own the career development plans of your team members.Reporting to the Head of Quality-Enterprise Informatics you will lead, collaborate, and partner with site quality leaders, business management teams, Philips Central teams, markets and functions on strategic initiatives and transformations.
This role may require travel up to 20%, including Global travel.You're the right fit if:
Youve acquired a minimum of 15 years experience in the FDA regulated medical device industry, with significant Class II device experience (PACS/RI related devices/software), demonstrating progressive/proven leadership experience, leading cross-functional, diverse teams in various aspects of Quality, such as establishing and implementing Quality strategy, Quality systems, design quality, post market surveillance and internal / external audit representation for large, Global, Matrix organizations.
You have Relevant training, experience and/or certifications (ASQ Quality Manager, Auditor, Six Sigma, DFSS, reliability engineering), Continuous Improvement methodologies and Quality tools such as Lean, Six Sigma, 5 Whys, Fishbone, etc.
You have strong familiarity with business process management frameworks including best industry practices related to QMS and experience in Quality system metrics through use of leading indicators to drive high performing systems and teams.
Youve acquired expert knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO13485, ISO14971, EUMDR.You have a minimum of a Bachelors Degree (Required) in Quality, Science, Engineering or similar technical discipline, Master's degree- preferredYou have strong Business insights, effective partnering, influencing, communication skills and change management experience.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.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 improve the lives of others.Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
Read more about our employee benefits.
If youre 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.Philips Transparency Details:
The pay range for this position is $128,000 to $236,000, annually.
The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
LI-PH1 Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.Job SummaryJob number:
512327Date posted :
Profession: Quality & RegulatoryEmployment type: Full time
