Client Details
A well-established organisation in the Pharmaceutical industry with a strong reputation for delivering high-quality products. This company values precision and innovation, offering an excellent environment for professional growth in Falmouth.
Description
Lead the development, implementation, and continuous improvement of QMS processes, ensuring robust control of procedures and quality records.
Ensure full compliance with ISO 13485 and ISO 9001 requirements across all quality activities, driving adherence to international standards throughout the product life cycle.
Provide expert quality engineering support across NPI projects, ensuring all quality deliverables meet internal and regulatory requirements.
Oversee verification and validation (V&V) activities, collaborating with technical SMEs to ensure effective testing of new products and processes.
Lead investigations into non‑conformances, deviations, and customer complaints through the eQMS Quality Event process.
Drive structured root cause analysis and deliver effective CAPA using tools such as 5 Whys, Fishbone, and FMEA.
Ensure product, design, and process changes are fully impact‑assessed, documented, and implemented in line with quality and regulatory standards.
Partner with cross-functional teams-Engineering, Manufacturing, Supply Chain, and Quality to deliver quality improvements aligned with global strategy.
Conduct internal audits, generate audit reports, and drive corrective actions to strengthen overall compliance and process performance.Profile
A successful Quality Engineer should have:
A strong background in Quality Engineering ISO9001 & ISO13485
Experience with quality management systems and standards.
Excellent problem-solving and analytical skills.
Ability to work collaboratively with engineering and manufacturing teams.
Strong attention to detail and commitment to maintaining high standards.
Relevant qualifications in engineering or a related field.Job Offer
£45,000 - £55,000 DOE
16 weeks Gender-neutral parental leave
15 days of extra paid caregiver leave
Comprehensive benefits package and support for professional development.
A collaborative and innovative work environment in the Industrial / Manufacturing industry.If you are passionate about quality assurance and are looking for a rewarding career in Portsmouth, apply now to join this exciting opportunity as a Quality Engineer
Salary description
£45000.00 - £55000.00 per year