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Purpose As a Senior Quality Engineer at BVI Bidford, you will provide essential cover for a maternity leave contract, reporting directly to the Quality Manager. In this role, you’ll lead quality assurance processes, drive strategic improvement initiatives, and mentor colleagues to strengthen our Quality culture. You’ll be a key partner to production and suppliers, ensuring our quality standards are upheld and continuously improved.
Key Responsibilities
- Continuously improve and maintain the Quality Management System to keep it best-in-class.
- Mentor QA team members, promoting a strong Quality mindset and culture of continuous improvement.
- Lead and support strategic quality initiatives and improvement projects.
- Develop, review, and ensure effective implementation of quality and purchasing specifications.
- Oversee validation of processes with engineering teams, ensuring compliance with regulatory standards.
- Investigate and resolve quality issues, driving corrective actions and supporting production.
- Act as a key liaison between production, quality, suppliers, and technical teams, applying quality tools like Six Sigma and Lean.
- Manage internal audits, CAPAs, NCRs, SCARs, and support external audits and notified body inspections.
- Prepare clear quality reports for management, offering insights and recommendations.
- Partner with Global Complaints, Vigilance, and Post-market Surveillance on root cause investigations.
- Ensure compliance with GMP, health & safety, and environmental policies.
Qualification
- A Bachelor’s degree in Engineering or a related Quality field (advanced degrees or Six Sigma certification a plus).
- At least 5 years in Quality Assurance, ideally in medical devices.
- Strong knowledge of FDA, ISO 13485, MDD, and EU MDR regulations.
- Certified internal auditor to ISO 13485, with experience leading audits.
- Solid experience with Six Sigma and Lean methodologies.
- Proven skills in problem analysis, resolution, and driving quality improvements.
- Ability to work in cleanroom environments and maintain strict contamination controls.
- Excellent communication and influence skills across teams.
- Proficiency in Microsoft Office and quality management systems.
- Commitment to continuous learning, confidentiality, and company Health & Safety policies.
- Must be UK-based; no visa sponsorship is offered for this position.
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
