Quality Assurance Specialist

Purpose

As a Quality Assurance Specialist at BVI Vierpolders, you will play a key role in maintaining and improving our Quality Management System in compliance with international standards for medical device manufacturing. You’ll drive continuous improvement across the organization by conducting audits, implementing corrective actions, supporting changes processes, and more.

Key Responsibilities

• Maintain, improve, and ensure compliance of the Quality Management System (QMS) with ISO 13485 and other applicable standards
• Support the implementation of new or updated products, processes, and procedures in line with regulatory requirements
• Manage non-conformities, complaints, and CAPAs, ensuring timely follow-up and documentation
• Coordinate and conduct internal and supplier audits, and support external audits
• Provide training and coaching to colleagues on quality-related topics
• Contribute to Management Reviews and monitor quality performance metrics
• Review and approve production releases and validation protocols/reports
• Provide hands-on quality support to operational departments on the production floor

Qualification

• Bachelor’s or Master’s degree (WO level) in Engineering, Biomedical Sciences, Chemistry, or a related field
• Available to work on-site in Vierpolders five days per week (full-time presence required)
• Fluent in Dutch and English; both written and spoken
• 1-3 years of experience in a quality or regulatory role
• Knowledge of ISO 9001 is required; experience with ISO 13485 is a strong plus
• Analytical mindset with strong attention to detail and a proactive, quality-driven approach
• A collaborative team player with excellent communication skills
• Strong multitasking abilities; able to manage various subjects and responsibilities simultaneously
• Auditing experience or certification (e.g., ISO 13485 lead auditor) is an advantage

Company 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), 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