Quality Assurance Officer

Purpose The QA Officer is responsible for upholding the highest quality standards in the production of ophthalmic surgical devices.This role centers on reviewing batch records, overseeing sterilization processes, and authorizing the final release of products to ensure compliance with all regulatory and safety requirements. Additionally, the QA Officer inspects incoming goods to verify conformity with specifications, directly contributing to the overall quality and safety of the devices used in ophthalmic surgeries.Key Responsibilities Authorities Conducts inspections of incoming goods to ensure compliance with quality and safety standards Reviews and authorizes the release of raw materials and components for production Performs batch record reviews and approves products for subsequent processsing stages Prepares, reviews, and approves sterilization records and authorizes the release of finished devices Manages and maintains the QA document archive, both in physical and electronic formats Oversees the review and approval of document change requests within the document management system Prepares documentation, such as Certificates of Conformity and Certificates of Sterility, as required Monitors the scheduling and completion of maintenance and calibration activities, ensuring all tooling and equipment are properly registered Identifies, documents, and tracks Non-Conformity Records (NCR) and manages quarantines products, including associated activities Supports investigation into internal quality non-conformities as required, under the direction of the Quality Assurance Group Leader Maintains and updates Part Inspection Standard documents as needed Represents QA in production meetings and collaborates on quality-related matters Promotes adherence to GMP (Good Manufacturing Practices) standards by providing training and guidance to production personnel Qualification Required Education, Experience, Skills And Competences MBO level 4+ or equivalent Preferred experience in Quality Assurance within the medical device or pharmaceutical industry Knowledge on GMP and relevant ISO standards for medical devices (e.g. ISO13485) Ability to interpret technical documentation such as technical drawings and specification sheets Proven ability to work in dependently, as well as collaboratively within a team Strong attention to detail, with the ability to identify and address quality issues effectively Flexibility to adapt to changing production schedules Basic proficiency in Microsoft Office (Word, Excel, Outlook) Effective verbal and written communication skills with both Dutch and English This role requires the employee to be on site at BVI Vierpolders for 5 days a week CompanyBVI® 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), and spans 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