Job Description
The role of Quality Officer involves supporting the Quality Manager in a variety of tasks.
Key Responsibilities:
* Coordinate the release of final products for medical devices and non-medical devices.
* Manage the release of article cards and bill of materials in the ERP system.
* Release specific raw materials, primary and secondary packaging materials.
* Support dummy recalls.
* Contribute to supplier management, including batch record reviews, supplier qualification, and evaluation.
* Provide administrative support to the Quality Manager for general supplier and product management.
* Assist with change control, process validation, and pilot batch production.
* Review and approve '02 PRFI's and underlying documents.
* Support the creation of manufacturing instructions, flowcharts, 08- and 10 PRFI's, test methods, and specifications.
* Perform supplier audits.
* Collaborate with the Quality Manager on stability management.
* Calibrate and verify lab equipment at Oystershell laboratory.
* Investigate and report non-recurrent complaints.
* Review and approve invoices, initiate purchase orders.
* Support waste and retain sample management.
Required Skills and Qualifications
To be successful in this role, you should have:
* Bachelor's Degree in Sciences (Pharmaceutical Sciences, Biomedical sciences, Bioengineering) or equivalent experience.
* Proven experience in a quality department or lab environment.
* Pharmaceutical or chemical background.
Technical Skills
You should possess:
* Excellent knowledge of Dutch and English.
* Familiarity with ISO standards; good knowledge of ISO13485 is a plus.
* Experience with root cause analysis, CAPA, complaint handling, stability testing, change control/MOC, and deviations.
* Proficiency in Microsoft Outlook, Word, and Excel.
* Affinity with ERP/DMS packages.
Competencies and Expected Professional Attitude
We are looking for someone with:
* Mature, positive personality and love for challenges.
* Passion for their work and strong organizational and administrative skills.
* Able to work accurately and structuredly.
* 'Can do' and hands-on mentality.
* Respect for deadlines and efficient work style.
* Strong team player with excellent communication skills.