Philips Head Quality - Benelux DACH zones 

Netherlands, North Brabant 

15244112

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.