Job Requisition: Senior Quality Engineer
Location: UK - Bidford
Application Deadline: Aug 1, 2025
Purpose
Provide cover for Senior Quality Engineer.
Key Responsibilities
Reporting to the Quality Manager, the Senior Quality Engineer oversees quality assurance processes at the BVI Bidford site. Responsibilities include leading quality initiatives, mentoring staff, collaborating with production and suppliers, and driving continuous improvement projects.
* Maintain and improve the Quality Management System
* Mentor QA team members to foster a quality-focused culture
* Lead strategic quality initiatives
* Develop and review quality specifications and procedures
* Validate processes ensuring regulatory compliance
* Investigate quality issues and implement corrective actions
* Coordinate with production, quality, and suppliers on quality tools and improvements
* Drive continuous improvement and develop a proactive quality culture
* Manage Internal Audit Program and support external audits
* Prepare reports for management review
* Oversee CAPAs, NCRs, and SCARs activities
* Collaborate on root cause investigations of incidents
* Maintain CAPA documentation and environmental monitoring activities
* Review validation protocols and reports
* Verify ECO process deliverables
* Ensure compliance with GMP and quality standards
Qualifications
o Bachelor's degree in engineering or related field; advanced certifications preferred
o At least five years' QA experience, preferably in medical devices
o Knowledge of FDA, ISO 13485, MDD, EU MDR regulations
o Certified internal auditor for ISO 13485
o Strong problem-solving skills and experience with quality improvement initiatives
o Experience with Six Sigma and Lean methodologies
o Ability to work in a cleanroom environment
o Excellent communication and interpersonal skills
o Proficiency in Microsoft Office and quality management systems
o Commitment to ongoing training and confidentiality
About BVI
BVI is a leading ophthalmic surgical business, dedicated to delivering innovative solutions for eye health. Our brands include Beaver, Visitec, Malosa, Vitreq, and PhysIOL, serving over 90 countries. We are committed to improving patient outcomes and fostering a collaborative, agile work environment.
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