Hiring Now: Quality Engineer Near You – Apply Today!
Your Next Quality Engineer Job Starts Here – Apply Now!
Quality Engineer
Job Posted: 4 hours ago
Salary: £ 45,000 - 55,000 / Annum
Job Type: Permanent
Location: Wembley, London
Expire in: a month
Job Description
About the Role
We are seeking a proactive and detail-oriented Quality Engineer to join our team in ensuring the highest standards of product quality and regulatory compliance within our medical device manufacturing operations. This role is critical to maintaining our commitment to patient safety and product excellence.
Key Responsibilities
Support and maintain the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality issues.
Lead and support internal and external audits, including regulatory inspections.
Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
Review and approve manufacturing documentation, including batch records, validation protocols, and change controls.
Monitor and analyze quality metrics to drive continuous improvement.
Provide quality support for sterilisation processes, including validation and routine monitoring.
Apply microbiological principles to assess contamination risks and support environmental monitoring programs.
Required Qualifications & Experience
Bachelor's degree in Engineering, Microbiology, Life Sciences, or a related field.
Proven experience in a medical device or pharmaceutical industry.
Solid understanding of manufacturing environments, preferably cleanroom operations.
Experience with sterilisation processes (e.g., EO, gamma, steam) and associated validation requirements.
Background in microbiology (Deirable)
Familiarity with regulatory standards such as ISO 13485, FDA QSR, and EU MDR.
Strong problem-solving skills and attention to detail.
Excellent communication and documentation skills.
Desirable Skills
Experience with risk management tools (e.g., FMEA, HACCP).
Knowledge of statistical techniques and data analysis.
Proficiency in quality software systems (e.g., TrackWise, MasterControl).Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancyBefore You Apply
Do not include the following in your job application, CV, or cover letter:
- Bank details.
- National Insurance number.
- Date of birth.
You should not be asked for payment or irrelevant information. If you have concerns about a job advert or employer, seek guidance on how to proceed.
Looking for your next career move? Join a top company hiring Quality Engineer job near me in Wembley, London! This is your chance to work on exciting projects, grow professionally, and enjoy a rewarding career with competitive pay and excellent benefits. Whether you're an experienced professional or looking to take the next step, this role offers the perfect opportunity to enhance your skills and make an impact. Don’t miss out—apply today via Vita CV and take your career to the next level!
© Vita CV: Registered in England and Wales (16187919).