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QMS Director

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Philips

20d ago

  • Job
    Full-time
    Expert Level
  • Pune
  • Quick Apply

AI generated summary

  • You must have a Master’s degree and 10+ years in medical devices, ISO9001/13485, FDA audits, strong strategic thinking, people management skills, and excellent communication abilities.
  • You will ensure QMS compliance, lead teams, transform QMS processes, manage audits and documentation, oversee quality systems, and drive continuous improvement initiatives in the MRI Business Unit.

Requirements

  • A Master university degree with a minimum of 10 years working experience in similar fields of expertise or 12 years experience with bachelor degree.
  • Experienced in diverse medical device companies and with internal / external audits and managing organizations certified under ISO9001, ISO13485 and FDA regulated. Including front room experience hosting FDA inspections.
  • Strong strategic thinking and a proven track record of global transformational and continuous improvement success in combination with great stakeholder management skills.
  • Strong people management skills to lead and motivate diverse teams in multiple locations effectively.
  • Excellent communication and persuasive abilities.

Responsibilities

  • Ensure our Quality Management Systems (QMS) remain effective and compliant.
  • Lead and inspire QMS and CAPA teams, along with Program Management.
  • Take charge of transforming our current QMS into a unified PQMS structure.
  • Orchestrate our QMS architectural design, including proposing changes to central compliance teams.
  • Manage and streamline all QMS processes, keeping them FDA-ready.
  • Oversee local and global Quality and Regulatory processes, ensuring they meet all requirements. And owning the PQMS governance.
  • Drive continuous improvement initiatives in the MRI Business Unit.
  • Manage all relevant areas of QMS, including but not limited to management review, document control, audits, etc.

FAQs

What is the primary responsibility of the QMS Director in the MRI Business Unit?

The primary responsibility of the QMS Director is to assure global quality and regulatory compliance of the various Philips Quality Management Systems at all MR locations worldwide.

What qualifications are required for the QMS Director position?

A Master’s degree with a minimum of 10 years of relevant experience, or a Bachelor's degree with 12 years of experience in similar fields is required.

Is experience with regulatory compliance important for this role?

Yes, experience in diverse medical device companies, internal/external audits, and managing organizations certified under ISO9001, ISO13485, and FDA regulations is crucial.

What type of initiatives will the QMS Director be responsible for driving?

The QMS Director will be responsible for driving continuous improvement initiatives within the MRI Business Unit.

How many days a week will the QMS Director be expected to work in the office?

The QMS Director will be expected to work in-person at least 3 days per week.

Will the QMS Director manage teams across multiple locations?

Yes, the role involves leading and motivating diverse teams across multiple locations effectively.

What type of skills are necessary for this role?

Strong strategic thinking, people management, excellent communication, and persuasive abilities are essential for this role.

Is hosting FDA inspections part of the responsibilities?

Yes, the QMS Director should have front room experience hosting FDA inspections.

What does Philips value in their work culture?

Philips believes that collaboration is key and values working together over isolation, hence the hybrid work model.

Are applicants encouraged to apply even if they don't meet all the stated experiences?

Yes, applicants are encouraged to apply even if they have many but not all of the necessary experiences, as they may still be suitable for this or other opportunities at Philips.

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Science & Healthcare
Industry
10,001+
Employees
1891
Founded Year

Mission & Purpose

Philips is a global technology company that focuses on healthcare, consumer lifestyle, and lighting solutions. They are dedicated to improving people's lives through meaningful innovation and advanced technologies. Their ultimate mission is to make the world healthier and more sustainable by providing innovative healthcare solutions that enhance patient outcomes and enable better living. Additionally, Philips aims to enhance people's daily lives with their consumer products, ranging from home appliances to personal care items. Through their lighting solutions, they strive to create efficient and sustainable lighting experiences for individuals and communities, promoting energy conservation and environmental responsibility.