Sr Quality Manager I&S

Doorsturen
 
  • Vakgebied Quality & Safety
  • Dienstverband Fulltime
  • Vacaturenummer VAC-10017231
  • Locatie Eindhoven
  • Type overeenkomst Secondment via YER
  • Branche Medical & Health

Over deze vacature

In this Quality role within Philips, your challenge will be to guide and support the Innovation and Strategy teams in accelerating our Quality journey. This involves being a confident advisor on approval, regulatory compliance, and quality management-related topics, to achieve timely implementation of standardized processes within I&S organizations.

Functie

Sr. Quality Manager, I&S

In this role, you have the opportunity to
In this Quality role within Philips, your challenge will be to guide and support the Innovation and Strategy teams in accelerating our Quality journey. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely implementation of standardized processes within I&S organizations.

You are responsible for
• Contribute to quality and compliance awareness levels
• Assists in implementing a standardized quality system and supports harmonization across the organizations within I&S.
• Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
• Manages compliance to applicable regulations and Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
• Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation.
• Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.

You are a part of
The Innovation and Strategy Quality Team. As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.

To succeed in this role, you should have the following skills and experience
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. Were looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.

• Bachelor degree or above in engineering/science
• Minimum of 6 years Q&R management experience in Product Design and Development, Manufacture or commercial organization , at least 2 years experience with focus on software
• Strong understanding of Medical Device product regulations and standards (e.g ISO 13485 )
• Strong interpersonal and influencing skills as well as analytical/statistical skills
• Ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends, acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems.
• Proven ability to lead diverse discipline teams, understand and identify relationships and interdependencies across multiple projects /functions
• Must be fluent in oral and written English
• ISO ISO9001 / 13485 internal auditor
• Experience with people management is preferred
• Knowledge and experience with Agile methodology is preferred

Bedrijf

With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare, and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.

Aanbod

You will be seconded via YER to Philips.

You are a part of the Innovation and Strategy Quality Team. As a result of Philips's renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being, and care of people around the world.

Profiel

To succeed in this role, you should have the following skills and experience: A person who is excited by the unique professional challenges that our Quality Transformation presents has strong technical competencies and demonstrates resilience in challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. Were looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.

  • Bachelor's degree or above in engineering/science.
  • Minimum of 6 years Q&R management experience in Product Design and Development, Manufacture or commercial organization, at least 2 years experience with a focus on software.
  • Strong understanding of Medical Device product regulations and standards (e.g., ISO 13485).
  • Strong interpersonal and influencing skills as well as analytical/statistical skills.
  • Ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends, acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems.
  • Proven ability to lead diverse discipline teams, understand and identify relationships and interdependencies across multiple projects /functions.
  • Must be fluent in oral and written English.
  • ISO ISO9001 / 13485 internal auditor.
  • Experience with people management is preferred.
  • Knowledge and experience with Agile methodology is preferred.
Doorsturen