You can't change the direction of the wind, but you can adjust your sails to always reach your destination
Over de functie
· Acts as Program Manager for PQMS/PEPF and EU MDR deployments in the Market organization, providing status updates to relevant stakeholders in a timely manner
· Manages the QMS transition of the PQMS/PEPF and EU MDR and manage the deployments in the Market organizations.
· Locally manages plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the Market OneQMS. This includes the drafting transition plans, execution of gap assessment against current QMS’s, action setting, follow-up on actions and closure of QMS Transition Plans.
· Ensures the creation and management of any local QMS documents are in line with the evolution of the PEPF, the PQMS and EU MDR requirements.
· Work with (Local) Business Process Owners, Business Process Experts, Market Deployment team, E2E Q&R, local Q&R and EU MDR Work Streams in order to manage PEPF, PQMS and EU MDR deployments
· Follows processes and operational policies in selecting methods and techniques for obtaining solutions
· Acts as advisor to subordinates to meet schedules and/or solve problems
Must have items
· Excellent organizational and Program/Project management skills with an attention to detail and follow-through
· Seasoned knowledge of ISO 9001 and ISO 13485 (preferable ISO 9001:2015 and ISO 13485:2016)
· Knowledge of MDD and EU MDR/IVDR
· Experience working in disciplined regulated industry and in applying automated technology.
· Strong analytic skills
· Demonstrated ability to understand and develop processes.
· Professional English written and verbal communication skills
· Ability to influence others to achieving goals
· Ability to work under a minimum of supervision
Nice to have items:
· Minimum of five years of similar work experience.
· Has a complete knowledge of company products and services
Philips is driven by their mission to improve the lives of 3 billion people per year by 2025, and every day they move closer to achieving their goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to their employees who share their passion for improving lives, they are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. They enable their employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.
At YACHT we will offer you a competitive benefits package in line with the seniority of the position.
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Sciences industry.
You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals.
Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer 06-13888330
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.