Quality Assurance Officer - growing company - medical devices
My client is focused on the field of Orthobiologic Ceramics and has costumers all over Europe, United States, Asia and other emerging markets. They are continuously looking to find and deploy technological and engineering advancements. Hence there is a lot of growth in the company so the environment is innovative, energetic and full of personal growth opportunities.
As a QA Officer within a fast growing contract development and manufacturing organization you will be mainly responsible for the overall and cross-departmental processes related to Quality Assurance.
- Assessment of paper and electronic batch records for completeness, clarity and ISO 13485 compliance.
- Responsible for designing, maintaining, safeguarding and optimizing the quality system.
- Responsible for the timely approval of QA-verified documentation (SOPs, Batch Records, work instructions etc.).
- Responsible for training (new) personnel. Maintaining training records for each employee and making sure that all personnel have received and finalized their training within a set timeframe.
- 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).
- Responsible for assessing change requests for consistency, relevance, ISO compliance and clarity.
What we are looking for in a candidate:
- A minimum of Bachelor degree in Science or comparable level through experience;
- At least 5 years relevant (international) experience in Quality Assurance preferably in a related field (medical devices, pharmacy);
- Ability to define and manage own tasks and schedules;
- Up to date knowledge of current ISO regulations.
- You acknowledge and assume responsibility for performance of your results, demonstrate ownership, keep commitments, and have a positive attitude in a changing environment;
- You are highly motivated, quality driven and a team player;
- Good knowledge of Dutch and English (verbal and written);
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Experience in an ISO 13485 environment is necessary.
If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!
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