Job Description

Job Requisition No

VN8272

Work Location Name

UK - Bidford

Worker Basis

Full Time

Worker Type

Employee

Applications Close Date

Aug 1, 2025

Purpose

Provide cover for Senior Quality Engineer.

Key Responsibilities

Reporting to the Quality Manager, the Senior Quality Engineer plays a crucial role in overseeing and advancing quality assurance processes at the BVI Bidford site. This position involves strategic responsibilities, leadership in quality improvement initiatives, and mentoring colleagues to foster a strong Quality mindset. The role focuses on leading quality assurance efforts in collaboration with production and suppliers, developing and implementing advanced quality improvement techniques, and driving quality improvement projects from initiation to completion.



Principal Duties and responsibilities:
Continuously improves and maintains the Quality Management System so it's always state-of-the-art; Provide mentorship to QA team members, fostering a Quality mindset and a culture of continuous improvement; Lead and contribute to strategic quality initiatives as directed by the Quality Manager; Develop, review, and ensure the consistent implementation of quality specifications, purchasing specifications, and procedures; Oversee the validation of new or existing processes in collaboration with process engineering, ensuring compliance with regulatory standards; Lead investigations and resolution of quality issues, offering advanced production support and implementing corrective actions; Act as the primary liaison between production, quality, supplier, and technical personnel to identify and implement quality tools (e.g., Six Sigma, Lean); Drive continuous improvement projects and contribute to the development of a proactive quality culture within the organization; Develops and manages the Internal Audit Program, including activities as auditor qualification, scheduling, execution and follow-up; Support in the coordination of activities related to notified body and other external audits; Prepare and present detailed summary reports for management review and other formal data review meetings (QRB), offering insights and recommendations for quality improvements; Coordinate and oversee activities related to Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), and Supplier Corrective Action Requests (SCARs); Collaborates with Global Complaints, Vigilance and Post-market Surveillance (CVP) on root cause investigations of reportable incidents; Act as Site CAPA Coordinator and maintenance of the ETQ CAPA module for Bidford; Coordinated Environmental Monitoring activities including but not limited to data presentation, trending and escalation according to internal procedures; Reviews all validation protocols and reports to ensure the process and product validation procedure is properly carried out; Act as an independent reviewer of the ECO process to verify if required deliverables are implemented and well documented; Ensure compliance with Quality standards and Good Manufacturing Practice (GMP) standards as outlined in the Company Quality policy;

Responsible for adhering to the requirements defined within the Company's health & safety, environmental and quality policies and systems

Qualification

Minimum of a Bachelor's degree in engineering or related Quality discipline; advanced degrees or certifications (e.g., Six Sigma Green Belt) preferred; Minimum of five years' experience in a Quality Assurance role, preferably within the medical devices industry; In-depth knowledge of medical device regulations (FDA, ISO 13485, MDD, and EU MDR) and experience with regulatory affairs; Certified internal auditor to ISO 13485, with experience leading audits; Exceptional problem analysis and resolution skills, with a track record of implementing effective quality improvement initiatives; Experience in Six Sigma techniques and Lean methodologies; Ability to work in a cleanroom environment, maintaining strict adherence to cleanliness and contamination control protocols; Strong interpersonal and communication skills, with the ability to influence and drive change across departments; Advanced computer literacy, with proficiency in Microsoft Office software and quality management systems; Willingness to participate in ongoing developmental training programs; Ability to maintain confidentiality in support of the Company and its Associates; Commitment to adhering to and promoting the Company's Health and Safety Policy.

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