Senior Quality Assurance Specialist (Yacht Life Sciences)
Yacht Life Sciences has a vacancy for a Senior Quality Assurance (QA) Specialist.
This vacancy is part of the Global Quality Assurance and Regulatory Affairs Department. Their vision is to continuously enhance business capabilities by using quality management and regulatory compliance as a tool for competitive advantage. It is their mission to develop global processes aimed to achieving streamlined and compliant business operations, both internally and in the interaction with suppliers.
As a Senior QA Specialist you will be responsible for the creation and maintenance of elements of the global Quality Management System (QMS). The role involves creating global processes and procedures in order to make simple and compliant with international regulations the interaction of your company with its suppliers and its affiliates worldwide. In addition, you will contributie to the practical, hands on implementation of QMS processes – e.g. investigating and following-up corrective and preventative actions, collecting and analyzing data, controlling suppliers, controlling documents, controlling production processes, auditing subsidiaries and suppliers, etc.
Furthermore, as a Senior QA Specialist your responsibilities include supporting the rest of the QA/RA team where and when required. Your role mostly includes dealing with Class I devices; however, the company portfolio also includes Class IIa and IIb devices.
Key skills, knowledge and experience:
- Bachelor/ Master degree in a related discipline (e.g. engineering, law, philosophy)
- Have previous experience in a similar role in a regulated industry (medical device or pharmaceutical)
- Be able to manage complex projects
- Be able to interpret regulations
- Be fully proficient in English, particularly written, and Microsoft Office.
- Knowledge of EU 2017/745, 93/42/EEC, ISO 9001, ISO 13485 and 21 CFR 820 is preferred
- Be willing to take on board new challenges with enthusiasm and professionality
- Strong but fair and data-driven personality
- Ability to prioritize workload
- 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 and maintain inter and intra departmental relationships
- Team-oriented with strong leadership and interpersonal skills
- Able to effectively adapt to change (environment, requirements, roles, objectives)
- Demonstrated leadership and change management ability)
This concerns a full-time position directly at our client.
Our client is an international company in optical retailing and delivers high quality and affordable eye care to more and more customers around the world. The high quality eye care offered by our client includes a wide range of services provided by its vision experts, prescription glasses including frames and lenses, contact lenses and contact lens care products, and sunglasses both plain and with prescription lenses. These products are offered through leading optical retail banners.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
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.