iSixSigma

Sr. Director, Quality Management Systems Connected Care

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Philips
Published
March 22, 2021
Location
Remote, Remote
Job Type

Description

In this role you have an opportunity to,

Be the Head of Connected Care PQMS, this is a critical position for Connected Care that is accountable for the transformation of all current local QMS to PQMS. The key goals for this role are to sustain current QMS, while simplifying it and Standardizing key processes and QMS structure.

You are responsible for

  • Compliant, efficient and effective QMS for the activities in scope with lean QMS structures and documents for Q&R.
  • Establishing and maintaining close working relationship with the formal owner (s) of QMS’ at CC (e.g., site/business manager or process line management).
  • Effective deployment of Philips QMS Standards, Procedures and E2E processes at Connected Care and their continuous improvement.
  • Delivering on internal audit planning and schedule completion along with effective follow-up QMS actions based on audit findings.
  • Owning CAPA process execution coordination to deliver encouraged results.
  • Leads/participates in the maintenance of the Philips-level QMS documents until such time as they are determined to be no longer applicable.
  • Ensuring effective QMS integration of new business acquisitions
  • Leading efforts to complete QMS software validation and training administration deliverables.

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. Passionate about 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.

To succeed in this role, you should have the following skills and experience

  • Bachelor’s Degree in Science, Engineering, Business Management, IT, or other relevant field; Masters Degree in Science/Engineering/Business Management desired.
  • A minimum of 12 years proven experience in Medical Device industry; 7 plus years of experience managing a team and being responsible for people management.
  • Project management experience leading sophisticated projects where not directly responsible for all required results. Project Management Certification desirable
  • Technical experience with medical device systems used to automate quality system processes.
  • Deep understanding of the Quality System the Quality System ISO 13485, 21 CFR Parts 803, 806 and 820), ISO9001 and EU-MDR
  • Regularly interacts with executives and regulatory agencies or certified bodies primarily on QMS related topics.
  • Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Experience in Six-sigma / problem solving methodologies; Six sigma Black Belt/ Master Black Belt certification desirable.
  • Ensures budgets and schedules meet business expectations
  • Validated ability to take independent action to initiate process improvement, work closely with upper management, work in a matrix organization and work independently with minimal mentorship.