As a QA Officer, you will uphold the highest quality standards in the production of ophthalmic surgical devices. You will review batch records, oversee sterilization processes, and authorize the final release of products, ensuring compliance with all regulatory and safety requirements. You will also inspect incoming goods to verify conformity with specifications, directly contributing to the quality and safety of devices used in ophthalmic surgeries.
Key Responsibilities- Inspect incoming goods to ensure compliance with quality and safety standards
- Review and authorize the release of raw materials, components, and finished devices
- Perform batch record reviews and approve products for subsequent processing stages
- Prepare, review, and approve sterilization records
- Manage and maintain QA document archives, both physical and electronic
- Review and approve document change requests in the document management system
- Prepare documentation such as Certificates of Conformity and Certificates of Sterility
- Monitor maintenance and calibration schedules, ensuring tooling and equipment are properly registered
- Identify, document, and track Non-Conformity Records (NCR), including quarantined products
- Support investigations into quality issues, collaborate in production meetings, and provide guidance on GMP standards to production personnel
- MBO level 4+ or equivalent
- Ability to work in the Netherlands without visa restrictions, and hold a permit allowing travel and work freely across the EU
- Fluent in Dutch and English
- Availability to work on-site at BVI Vierpolders 5 days per week
- Experience in Quality Assurance within the medical device or pharmaceutical industry (preferred)
- Knowledge of GMP and relevant ISO standards for medical devices (e.g., ISO 13485)
- Ability to interpret technical documentation such as drawings and specification sheets
- Flexibility to adapt to changing production schedules
- Basic proficiency in Microsoft Office (Word, Excel, Outlook)
BVI® is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), andspans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com
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