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Philips Head Quality - Benelux DACH zones 
Netherlands, North Brabant 
15244112

02.08.2024
Head of Quality - Benelux and DACH zones
Job Description

efficiently, thereby contributing to improve people’s lives.

Your role:

is to assure compliance to Medical Device Regulations and Quality system requirementsin all aspects of operational quality. This is divided between 4 focus areas:

General Quality

  • Promoting Quality awareness throughout the organization under own responsibility and supporting functional leaders in fostering Quality culture

  • Partnering with other functions to ensure compliance to all relevant regulations and internal Philips requirements

  • Fostering continuous improvement through involvement in process excellence activities

  • Representing Quality in business and commercial projects, ensuring quality support to others for the concerned Functional domain

  • Ensuring Competent Authorities relationship governance is in place in the countries under own responsibility

  • Managing and developing Quality resources in his/her team

  • Coordinating and facilitating the activities within the zone(s) under own responsibility

Quality Management

  • Leading QMS deployments in the Market, including impact assessment in respect to People and budget

  • Steering Market Quality Representation in Europe or IR transformations programs, QMS market reviews including ICQA and related impact assessments

  • Leading implementation of quality projects, transformation and transition plans, including Merger and Acquisition integrations and deviations

  • Steering Quality contribution in the development & deployment of compliant solutions/LSPs to customers

  • Overseeing consistent document and record controls execution

  • Leading training development, assignment and monitoring

  • Supporting the Preparation & Coordination of Quality Management Reviews in Region Europe

  • Overseeing consistency of QMS execution

  • Overseeing hosting / coordination of local internal and external audits

  • Overseeing execution of CAPA intake, Owning CAPAs related to quality processes and managing audit findings

  • Steering Quality contribution to Trade Partners management

  • Leading monitoring and achievement of quality goals / KPIs

  • Leading operational quality activities / issues resolution

  • Setting in place support for sustaining Good Documentation Practices (GDP)

Corrections and removals

  • Ensuring support to IR CoE C&R for strategic meetings and alignment with Businesses

  • Leading timely execution of Corrections & Removals (C&R) strategies as applicable for the local organization

  • Ensuring timely reporting and closure of FSCA to Competent Authorities within the Region

  • Ensuring timely completion of Due Diligence within the Region

  • Driving C&R alignment and continuous improvement

  • Ensuring review of Quality communication regarding C&R when necessary

  • Ensuring escalations to relevant partners for C&R

Customer Advocacy

  • Ensuring stimulation of customer feedback process & execution of complaint handling process

  • Ensuring connections with global partners on complaint management

  • Overseeing escalation to relevant parties to ensure customer satisfaction

  • Leading execution of non-product customer feedback and third-party products complaints handling processes

  • Ensuring review of Quality communication to customers when necessary

  • Leading continuous improvement in Customer Relationship

  • Overseeing appropriate Customer Feedback process implementation by Channel Partners

  • Leading Advisory and Support to Service Record reviewers for content and on Good Documentation Practice

You're the right fit if:

  • You have a University degree level (Life Science, Pharmaceutical, Medical Engineering, or similar technical discipline)

  • Comprehensive Quality System understanding of relevant international ISO standards (ISO 13485, 9001, and 14971 (Risk management)

  • >5 years of experience in a management role within medical devices

  • In depth knowledge of key requirements for Post Market Surveillance, Complaints Handling, and CAPA and experience interfacing with competent authorities

  • You have strong leadership skills, you are a strong listener, able to motivate the team and keep them motivated.

  • You are open to changes, you can delegate and prioritize work, you have strong influencing skills.

If not already located in the Netherlands, relocation to the Netherlands is required.
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