PMS Quality Program Manager
Philips
Eindhoven, Noord-Brabant, Netherlands
3 dagen geleden

Job Description

In this role, you have the opportunity to

Use your voice and expertise to positively impact Post Market Surveillance teams in the markets, our business, and health technologies that will improve health, well-being, and care of people around the world.

You will provide guidance and support for investigations and projects initiated by the Markets Post Market Quality functions.

Projects are related to initiating and deploying PMS-related processes and supportive tools, Corrective Action-Preventive Action Management, or Continuous Improvement projects.

You are responsible for

  • Driving the Customer Feedback Management (CFM) Project with the Market to Order Organization, gathering market feedback as input to the design, build and test of system and process.
  • Work with cross-functional teams to ensure project milestones (deployment), timelines, and quality targets are compliant and aligned with business needs.
  • Act as a Program Manager for PMS International Markets and manage project management aspects of PMS transformational initiatives, investigations, and CAPA activities, including gaining the commitment of cross-functional resources, i.
  • e., customer service, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.

  • Investigate and implement Corrective Action-Preventive Actions to structurally improve the Quality Management Systems, e.
  • g. based on assessed audit findings.

  • Initiate and be a team member of Post Market Continuous Improvement Kaizens together with the Markets Quality and Service organizations.
  • Ensure that Post Market Surveillance work instructions are being followed across International Markets per QMS requirements and initiate corrective actions.
  • Perform timely, detailed investigational tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem-solving.
  • Ensure CAPA action plans are robust and executed promptly, with the appropriate sense of urgency. Represent PMS during audits and CAPA Review Board meetings.
  • Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
  • Establish KPI with investigation and project leads and present a summary to senior leadership.
  • You are a part of

    The International Markets Quality organization, reporting to the Business Process Expert (BPE) PMS International Markets.

    You will be based in Amsterdam or Eindhoven (High Tech Campus). You will drive PMS Continuous Improvement initiatives across markets and associated businesses and functions.

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

  • Bachelor’s degree in an engineering or scientific-related field or equivalent technical experience
  • 5+ years’ work experience in quality functions, Post Market Surveillance Quality, Customer Feedback Processes, Product Risk Management & CAPA is required;
  • experience in Medical related industry is required.

  • Trained in lean methodologies, i.e., Daily Management and Problem-Solving Process tool
  • Lean 6-Sigma Green or Black Belt project experience
  • Demonstrated deep knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
  • Knowledge of appropriate global regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
  • Demonstrated ability to collaborate with the business and effectively interact with and influence employees, and managers on all levels.
  • Strong Project Management skills, methodologies and best practices, including ability to manage CAPA activities, in a matrix organization.
  • Experience seeing projects through the full life cycle.

  • Ability to analyze data and apply statistical techniques, and assess risk as it pertains to the CAPA.
  • Proficient with querying data from Salesforce.com.
  • In return, we offer you

    We welcome you to a challenging, innovative environment with great opportunities for you to explore.

    Our benefits are very competitive and designed around your preferences :

  • A market conform salary
  • 25 Days of leave and the possibility to purchase up to 20 extra days off annually
  • A variable bonus based on both Philips results and personal performance
  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
  • Solid company pension scheme and attractive collective health insurance package
  • Opportunity to buy Philips shares and products with discount
  • Healthy work-life balance
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