Quality Assurance Specialist
Posted 5 days ago by Cure Talent
£55,000 Per year
Undetermined
Undetermined
London Area, United Kingdom
Summary: The role of QA Specialist at an innovative MedTech company involves maintaining and improving the ISO 13485 Quality Management System (QMS) while ensuring compliance with global regulatory requirements. The position is initially for a 9-month contract and requires oversight of Quality Events, CAPAs, and Change Controls. The ideal candidate will have a background in Quality Assurance within the Medical Device industry and relevant certifications. This opportunity is ideal for those looking to contribute to advancements in ear and hearing healthcare technology.
Key Responsibilities:
- Maintain and improve the ISO 13485 QMS.
- Oversee Quality Events, including deviations, non-conformances, CAPAs, and Change Controls.
- Generate and revise SOPs and associated documentation.
- Support regulatory compliance activities, including audits, customer complaints, and employee training.
- Generate and maintain Design History Files and Technical Documentation to support global market registrations.
- Participate in risk management activities, ensuring effective risk mitigation in products and processes.
Key Skills:
- BSc in Science or a related field.
- Proven Quality Assurance experience within the Medical Device industry.
- Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR.
- Experience with EN 62304 (desirable).
- Certified Internal or Lead ISO 13485 Auditor.
- Experience using an eQMS.
Salary (Rate): £55,000.00 yearly
City: London Area
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Cure Talent is delighted to be working with an innovative MedTech company revolutionising ear and hearing healthcare! With their ongoing growth and exciting projects, we have a fantastic opportunity for a QA Specialist to join their highly motivated team on an initial 9 month contract. As a QA Specialist, you will play a key role in maintaining and continuously improving the ISO 13485 QMS. You will oversee Quality Events, CAPAs, Change Controls, and Quality Metrics while supporting compliance with QSR, ISO, CE, and other global regulatory requirements.
Key Responsibilities:
- Maintain and improve the ISO 13485 QMS.
- Oversee Quality Events, including deviations, non-conformances, CAPAs, and Change Controls.
- Generate and revise SOPs and associated documentation.
- Support regulatory compliance activities, including audits, customer complaints, and employee training.
- Generate and maintain Design History Files and Technical Documentation to support global market registrations.
- Participate in risk management activities, ensuring effective risk mitigation in products and processes.
The Ideal Candidate Will Have:
- BSc in Science or a related field.
- Proven Quality Assurance experience within the Medical Device industry.
- Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR.
- Experience with EN 62304 (desirable).
- Certified Internal or Lead ISO 13485 Auditor.
- Experience using an eQMS.
If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!