You can't change the direction of the wind, but you can adjust your sails to always reach your destination
Over de functie
Main purpose of the role
Key responsibilities of the role include:
A. Establishing and continuously improving global CAPAs, recalls and stock recoveries processes.
B. Ensuring CAPAs, recalls and stock recoveries are executed in compliance with international regulations.
C. Driving and measuring progress of CAPAs, recalls and stock recoveries.
D. Documenting CAPAs, recalls and stock recoveries.
E. Validating and closing CAPAs.
F. Documenting risk assessments liaising with the complaints handling unit and the risk management team.
G. Assisting QARA management to communicate with competent authorities worldwide.
H. Flagging to QARA management any QARA issues detected.
I. Ensuring QARA KPIs are achieved.
J. Ensuring NCs detected during internal and external audits are resolved and documented through CAPA process.
K. Support QARA auditing activities both internal and external.
L. Supporting the QARA team when and where required.
The role is based in Schiphol. However, occasional international travel will be required.
Key performance indicators
Performance will be measured based on QARA KPIs.
Required qualifications/level of education
- Ideally you should have experience in a regulated industry (medical device preferred).
- An academic degree in a related discipline (e.g. science, engineering or philosophy).
Core competencies/ Personal attributes
- Ability to work cross-functionally within a global organization.
- Strong but fair and data-driven personality.
- Ability to prioritize workload.
- Willingness to work hands-on with procedures and records.
- Ability to distill information and take agreed decisions when dealing with conflicting stakeholders.
- Strong planning, problem analysis and resolution, and organizational skills.
- Detect deviations from intended workflows and processes, with exceptional attention to details.
- Learn quickly and effectively, approaching new challenges by taking initiative.
- Scope, manage and prioritize multiple small projects simultaneously.
- Effectively present information to others, including senior management of the company and its subsidiaries.
- Communicate clearly with all areas of the business.
- Team-oriented with strong leadership and interpersonal skills.
- Able to effectively adapt to change (environment, requirements, roles, objectives).
- Demonstrated leadership and change management ability.
- Learning agility.
Key skills, knowledge and experience
- Be able to interpret regulations.
- Have previous experience in a similar role in a regulated industry (preferably medical device).
- Be willing to take on board new challenges with enthusiasm and professionality.
- Be fully proficient in English, particularly written, and Microsoft Office.
- Knowledge of EU 2017/745, 93/42/EEC, ISO 13485, 21 CFR 820.100, 21 CFR 803 and 21 CFR 806 is desirable.
Future potential/ learning agility/ growth opportunities
You will work cross-functionally with a wide variety of international stakeholders, and therefore there is possibility to learn and grow professionally from the interaction with each of those.
Our client is passionate about customer satisfaction and develops the people to look for growth potential within the job and within the company. Their preference is to always promote internally where possible. So, wherever people start, there’s always somewhere else to go. We strive for continuous improvement and our new recruits help us to further raise the future potential of our company.
Their whole business is full of people who have gone on to achieve a successful career through experiencing a variety of different roles in different locations and areas of our business. They continually support and develop their people who have the desire, ambition and potential to grow.
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies. This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer
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.