Quality Engineer

Physiol; United Kingdom; Remote; GBP 42,000 - 64,000; Full time

Job summary

PhysIOL is seeking a Quality Engineer to support QA activities at the Bidford site, ensuring compliance with GMP and ISO 13485, and driving product quality improvements.

You will own NC and CAPA actions, investigate complaints, and collaborate with global CVP for reportability and health hazard analyses; assist ECOs and documentation maintenance.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field; equivalent QA experience considered.
• Minimum 3 years in a Quality Assurance role within medical devices.
• Experience with NC and CAPA processes and complaint investigations.

Responsibilities

• Lead investigations of customer complaints and communicate findings to customer service.
• Collaborate with Global CVP on reportability assessments and health hazard analyses.
• Support NC investigations and own NC actions to timely closure.
• Own CAPA actions and drive timely implementation and closure.
• Support ECO administration with proper documentation and adherence to procedures.
• Assist cross-functional teams to apply quality tools for process control.
• Contribute to continuous improvement and a proactive quality culture.
• Provide SME support for notified bodies and external audits.
• Prepare summaries for QRB and management reviews with actionable insights.
• Review validation protocols/reports to ensure proper execution; ensure GMP compliance.
• Adhere to health & safety, environmental, and quality policies.

Skills

Problem-solving

Analytical skills

Communication skills

Collaboration

QMS proficiency

Documentation control

Multi-tasking

Education

Bachelor's degree in engineering, life sciences, or related field

Tools

QMS software

MS Office

Job description

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

Key Responsibilities

• Execute activities related to customer complaints, including conducting investigations, preparingsummary evaluation letters, and communicating findings with customer service teams;
• Collaborate with the Global Complaints, Vigilance and Post-market Surveillance (CVP) group onreportability 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 timelyimplementation and closure;
• Support the administration of Engineering Change Orders (ECOs), ensuring proper documentation andadherence 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 qualityculture 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 reviewmeetings (QRB), offering insights and recommendations for quality improvements;
• Reviews all validation protocols and reports to ensure the process and product validation procedure isproperly carried out;
• Ensure compliance with Quality standards and Good Manufacturing Practice (GMP) standards asoutlined 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 qualityassurance 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 devicesindustry;
• Familiarity with medical device regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, andother 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 investigationseffectively.
• 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 toadhering 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), andspans 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