At a Glance
- Tasks: Ensure quality compliance for medical devices and develop training materials.
- Company: Leading medical devices company with a focus on innovation.
- Benefits: Competitive pay, fully remote work, and flexible hours.
- Other info: Opportunity for professional growth and collaboration with experts.
- Why this job: Join a dynamic team and make a difference in healthcare technology.
- Qualifications: Experience in quality assurance within the medical device sector required.
The predicted salary is between 40 - 40 £ per hour.
- Role: Quality Assurance Engineer – Medical
- Devices
- Type: 6 Month
- Contract
Location: Fully Remote with occasional visits to Birmingham site Are you a Quality Assurance Engineer contractor looking for your next contract?
I'm currently representing my Medical Devices client based in Birmingham who are looking for a Quality Engineer to join them on a contract basis.
- Quality Engineer - Job Description
- Supplier & Purchasing Oversight: Ensure supplier and purchasing processes comply with regulations; develop supporting documents, supplier controls, and quality agreements.
- Labelling Compliance: Review and create procedures for product and software labelling to meet all regulatory requirements.
- Regulatory Registration Support: Prepare documentation packs for global device registrations; maintain a master list of active registrations and develop related procedures.
- Technical Documentation & Risk Management: Maintain regulatory files, support risk management activities, and document process risks per ISO 14971.
- Quality Data & Trend Analysis: Develop systems for collecting and analysing quality data to identify trends and drive improvements.
- Training Development: Create training materials on applicable regulations and standards and implement a refresher training process for key quality procedures.
- Project Engineer - Essential Experience/Skills/Qualifications
- Proven experience in quality assurance and regulatory affairs within the medical device sector, including creating procedures and technical documentation.
- Strong analytical, problem-solving, and detail-oriented skills with the ability to manage multiple projects and priorities.
- In-depth knowledge of international medical device regulations and standards (e. g., MDSAP, EU MDR 2017/745, ISO 13485, ISO 9001, ISO 14971).
- Excellent regulatory writing, communication, and interpersonal collaboration skills.
- Proficient in using QMS tools and electronic document management systems; experienced with MS Office, Share Point, and MS Teams.
- Highly organized, professional, and collaborative; effective in team environments and capable of independently planning and managing tasks.
If you are a Quality Assurance Engineer and are interested, please apply now with your latest CV.
We think you need these skills to ace Remote Contract Quality Assurance Engineer in Stoke-on-Trent
Quality Assurance
Regulatory Affairs
Supplier Oversight
Labelling Compliance
Regulatory Registration
Technical Documentation
Risk Management
