07 September 2022 – Job opportunity QA associate at Medace
Medace is a unique service provider in the medical industry. Located in the South of the Netherlands, Medace offers a full service ISO13485 certified work-learning environment where customers are trained and guided in developing their medical product towards clinical implementation and market introduction. From building the product technical dossier needed for clinical validation to producing the clinical grade product in our state-of-the-art research and cleanroom facilities. Our clients range from academic groups to corporates, with the main audience being startups active in the field of Medical Devices and Cell Therapy. This results in a vivid biomedical co-working space where entrepreneurship and science thrive. For more information about our company visit www.medacespace.com.
What are we looking for?
The ideal candidate has previous quality experience, is a team player and critical thinker, with the ability to ensure a product or service meets the established ISO standards of quality. You are able to define quality criteria and have strong written and verbal communication skills to provide concise and clear quality documentation and guidance. You have a high level of adaptability and are open to broaden and share your quality expertise in different biomedical product development areas. As QA associate, you are a member of the Medace (Quality) team and will be directly working with the Quality Manager Medical Devices to maintain and improve Medace’s QMS as well as providing quality services to our clients.
QA associate responsibilities
- Provides advice, facilitation and training to the multi-disciplinary teams (Clients) in regulatory processes
- Provides hands-on support in quality processes (e.g. write and review quality documentation, provide quality training such as FMEA training)
- Works with the quality and operations team to develop quality control methods
- Help set up and conduct trainings on quality concepts and tools
- Support internal/external audits
QA associate qualifications
- Bachelor’s degree or equivalent experience in engineering and/or biomedical sciences
- 1-2 years’ of expertise in QA support
- Experience with ISO standards like ISO 13485 and quality events (non-conformities, CAPA, change control) in the medical field
- Experience with working under a Quality Management System and/or maintaining a Quality Management System
- Experience in technical writing, creating SOPs, verification and validation protocols
- Acquainted in providing support during audits (internal, external, supplier)
- Basic knowledge of Risk Management processes (FMEA, ISO 14971)
- Knowledge of MDR 2017/745 would be an add on
- Independent thinking and planning ability
- Initiator, self-propelling
- Excellent command of English, spoken and written
- Good communication/presentation skills
- Critical, accurate, and precise
- Team player
- Multitasker with high stress level
- Proactive and service mindset to deliver the highest quality possible
What we offer
Medace offers a challenging job in an inspiring and ambitious young organization. Communication lines are short and personal initiative is highly stimulated and appreciated. We offer a full time position via a one year contract with a possible prospect on a permanent employment. We are committed to support your professional and personal development and give you the opportunity to cooperate with talented people in an informal, transparent and open culture. Working closely with the QA Manager will help adapt your skills in this role.
Interested in joining Medace as QA associate?
Please submit your motivation and resume via firstname.lastname@example.org before September 30th. If you have any questions regarding this vacancy, please contact Gertjan Geelen (QA Manager Medical Devices) via mail: email@example.com or phone: +32 (0)4 7540 1283
Acquisition as a result of this vacancy is not appreciated!