Senior QA Specialist
4 days left
- Experience Level
- Experienced (non-manager)
An exciting Medical Device company are searching for a Senior Quality Assurance Specialist to join a winning team that delivers products and services to industry leaders in the pharmaceutical, orthopaedic, dental and aesthetic sectors.
This is a growing organisation that are heavily investing in new equipment, people, and digitalising their QMS. The ideal candidate will be proactive by nature, creative in the way they resolve issues, and someone that thrives off challenging situations.
The company have a great attitude towards employee improvement, stating that you will be given the opportunity to undertake a wide range of training to improve your expertise wherever needed.
- Assessment of paper and (electronic) batch records for completeness, clarity and ISO 13485 compliance.
- Responsible for designing, maintaining, safeguarding and optimising the quality system.
- Responsible for the timely approval of QA-verified documentation (SOPs, Batch Records, work instructions etc.).
- Responsible for training (new) personnel
- Responsible for registering, investigating and reporting internal and external complaints.
- Responsible for coordinating, conducting and/or supervising internal and external audits.
- Initiate corrective and preventative measures (CAPAs).
- Bachelor degree in Science or equivalent experience
- 5+ years experience in Quality Assurance in medical devices and/or pharmaceutical industries.
- Up to date knowledge of current ISO regulations.
- You are highly motivated, quality driven and a team player;
- Good knowledge of Dutch and English (verbal and written);
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Experience in an ISO 13485 and/or pharmaceutical environment is necessary.
With exciting and challenging projects coming up this is seen as a key appointment, with lots of opportunity to showcase your skill set. Please apply today for a quick and confidential call back.
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