Quality Engineer

BVI Medical, Inc.; England; On-site; GBP 40,000 - 55,000; Full time

Job summary

BVI Medical, Inc. is seeking a Quality Engineer to support QA activities across the product lifecycle, ensuring regulatory compliance, managing complaints, NCs and CAPA, and contributing to health hazard analyses.

The role involves collaborating with global teams, administering ECOs, and driving a proactive quality culture at the Bidford site, with a focus on GMP standards and ISO 13485.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field; equivalent QA experience in medical devices.
• Minimum three years in a QA role, preferably in medical devices.
• Familiarity with ISO 13485, FDA 21 CFR Part 820 and related standards.
• Hands-on NC and CAPA process experience; complaint investigations.

Responsibilities

• Coordinate and execute QA activities to ensure regulatory compliance and product quality.
• Manage customer complaints, NC investigations, and CAPA actions.
• Collaborate with CVP and global teams on reportability assessments and health hazard analyses.
• Administer ECOs to support continuous improvement at the Bidford site.
• Provide SME support to notified bodies and external audits.
• Prepare detailed reports for QRB and management reviews.

Skills

Quality Assurance

Root cause analysis

CAPA management

GMP compliance

Non-conformance handling

ECO administration

Collaboration with global teams

Document control

Education

Bachelor’s degree in engineering or life sciences

Quality assurance in medical devices

Tools

Quality Management Systems (QMS)

Job description

Purpose

Reporting to the QA Manager, the Quality Engineer is responsible for supporting and coordinating key quality assurance activities to ensure compliance with regulatory requirements and enhance product quality. This role involves managing customer complaints, non-conformances, and CAPA actions, as well as collaborating with global teams on complaint reportability assessments and health hazard analyses. Additionally, the QA Engineer contributes to the administration of Engineering Change Orders (ECOs) to support continuous improvement efforts at the Bidford site.

Key Responsibilities

• Execute activities related to customer complaints, including conducting investigations, preparing summary evaluation letters, and communicating findings with customer service teams;
• Collaborate with the Global Complaints, Vigilance and Post‑market Surveillance (CVP) group on reportability assessments and provide input for health hazard analyses;
• Support non‑conformance (NC) investigations as requested by the QA Manager;
• Act as the owner for non‑conformance actions, ensuring timely resolution and documentation;
• Serve as the owner for CAPA (Corrective and Preventive Action) actions, driving their timely implementation and closure;
• Support the administration of Engineering Change Orders (ECOs), ensuring proper documentation and adherence to quality procedures;
• Support production, quality, supplier, and technical personnel to identify and implement quality tools (e.g., Six Sigma, Lean) for effective management and control of processes;
• Support continuous improvement projects and contribute to the development of a proactive quality culture within the organization;
• Provide support as Subject Matter Expert (SME) 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;
• Reviews all validation protocols and reports to ensure the process and product validation procedure is properly carried out;
• 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

• Bachelor’s degree in engineering, life sciences, or a related field. Equivalent experience in quality assurance within the medical device or regulated industry will also be considered;
• Minimum of three years’ experience in a Quality Assurance role, preferably within the medical devices industry;
• Familiarity with medical device regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and other relevant standards;
• Hands‑on experience with NC and CAPA processes, as well as complaint investigation procedures;
• Strong problem‑solving and analytical skills, with the ability to conduct root cause investigations effectively.
• Excellent written and verbal communication skills for interaction with internal teams and customers.
• Proficiency in quality management systems, document control tools, and basic office software.
• Ability to manage multiple tasks and prioritize effectively in a fast‑paced environment.
• Strong collaborative skills to work with global teams and cross‑functional stakeholders. 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