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 Bournemouth
Quality Assurance
Regulatory Affairs
Supplier Oversight
Labelling Compliance
Technical Documentation
Risk Management
ISO 14971
