- 05 februari 2018
- vacaturenummer: 9049724
- Ensures compliant and effective QMS’s are maintained in scope
- Accountable for the transformation of all current QMS’s parts in scope towards the single PQMS structure.
- Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.
- Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope
- Ensures Q&R requirements are effective in all processes in scope.
- Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope
- QMS non- conformities and CAPA/Non-conformity resolution
- New QMS functionality deployed on time and within budget constraints
- Current system functionality deployed across a large user group leveraging compliance capabilities and improved efficiency
- Leadership and team performance indicators
- Recognition by business leadership as key resource to the business
- Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels of HT.
- Manages the transition/deployment of the PQMS and manage its deployment.
- Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.
- Locally manages plan for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS.
- Ensures the addition and management of any local QMS documents in line with the evolution of the PEQS and the PQMS.
- Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.
- Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
- Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
- Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems.
- Develops and administers schedules, performance requirements.
- Has budget responsibilities.
- Responsible for managing a part of a business process or function.
- Manages, perhaps through subordinate supervisors, the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing. In some instances this manager may be responsible for a functional area and not have any subordinate employees.
- Incumbents at the Manager level may manage only individual contributors and may carry their own targets.
- May manage own budget > € 1 M
- Strong influence on CoNQ: > € 10 M.
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98- 282), Japanese MHLW Ordinance 169, and ISO 9001.
3+ years of related experience in a medical device or regulated industry.
Experience working in disciplined regulated industry and in applying automated technology
Experience validating activities for applications
Experience with business application implementation projects, including being an active contributor on project with scheduled deliverables
Demonstrated ability to understand and develop processes
Demonstrated ability to interact and communicate in English, including demonstrable writing, speaking and comprehensive skills; ability to communicate across levels of the organization
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.
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.
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.
Deze vacature wordt via YACHT aangeboden. Het solliciteren en verdere contact verloopt via YACHT.