Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Ensure medical devices are safe by conducting biological risk assessments and managing testing.
- Company: Join a leading company in the medical device industry focused on patient safety.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real difference in patient safety while working with innovative technologies.
- Qualifications: Degree in relevant field and experience with ISO 10993 standards required.
- Other info: Fast-paced environment with a focus on continuous improvement and teamwork.
The predicted salary is between 36000 - 60000 £ per year.
Are you someone who enjoys digging into the detail and making sure products are not just compliant, but genuinely safe for patients? If you have a strong background in biocompatibility and enjoy working in a fast-paced, regulated environment, this could be a great next step for you.
In this role, you'll play a vital part in ensuring medical devices and materials are biologically safe throughout their lifecycle from new product development through to products already on the market.
What you'll be doing:
- Taking ownership of biological safety activities and working closely with internal teams, suppliers, and external laboratories.
- Performing biological risk assessments and characterisation for medical devices (NPD and in-market remediation).
- Developing biocompatibility strategies, test plans, and protocols in line with ISO 10993.
- Coordinating and managing biocompatibility testing with external labs and suppliers.
- Carrying out material characterisation and maintaining databases of MSDS and toxicological data.
- Producing clear, high-quality documentation such as Biocompatibility Evaluation Plans and Reports.
- Reviewing and approving biocompatibility test results.
- Ensuring ongoing compliance with global regulatory requirements and standards.
- Supporting change management activities (ECOs) with biocompatibility input.
- Responding to customer and stakeholder technical queries.
- Contributing to continuous improvement across processes and ways of working.
- Managing your workload proactively while supporting colleagues where needed.
What we're looking for:
- Essential: Degree (or Masters) in Biochemistry, Chemistry, Chemical Engineering, (Bio)Medical Engineering, Materials Science, or a related discipline.
- Experience working to ISO 10993 standards.
- Experience in a regulated industry (medical devices, pharma, or similar).
- Strong report writing and data analysis skills.
- Excellent attention to detail and organisational skills.
- Clear and confident written and verbal communication.
- A proactive approach to problem-solving and workload management.
Desirable:
- Knowledge of MDD (93/42/EEC) and MDR (2017/745).
- Experience working within an ISO 13485 quality system.
- Familiarity with FDA guidelines and requirements.
- Experience with ISO 14971 risk management.
- Experience using a Product Lifecycle Management (PLM) system (e.g. Windchill).
- Confidence working with stakeholders at different levels.
Quality Engineer in Mountain Ash employer: Accelero
Contact Detail:
Accelero Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer in Mountain Ash
✨Tip Number 1
Get to know the company inside out! Research their products, values, and recent news. This will help you tailor your conversations and show that you're genuinely interested in being part of their team.
✨Tip Number 2
Network like a pro! Reach out to current employees on LinkedIn or attend industry events. Building connections can give you insider info and might even lead to a referral, which is always a bonus!
✨Tip Number 3
Prepare for interviews by practising common questions related to biocompatibility and quality engineering. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your experience effectively.
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email reiterating your interest in the role can keep you fresh in their minds and show your enthusiasm for the position.
We think you need these skills to ace Quality Engineer in Mountain Ash
Some tips for your application 🫡
Understand the Role: Before you start writing your application, take a good look at the job description. Make sure you understand what we're looking for in a Biocompatibility Engineer and how your skills align with the responsibilities outlined.
Showcase Your Experience: When detailing your experience, focus on your background in biocompatibility and any relevant projects you've worked on. Highlight your familiarity with ISO 10993 standards and any regulated environments you've been part of.
Be Clear and Concise: We love clear communication! Make sure your application is well-structured and free from jargon. Use straightforward language to explain your qualifications and experiences, especially when discussing technical aspects.
Apply Through Our Website: Ready to take the plunge? We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates!
How to prepare for a job interview at Accelero
✨Know Your Stuff
Before the interview, make sure you brush up on ISO 10993 standards and biocompatibility principles. Familiarise yourself with the specific responsibilities of the role, especially around biological risk assessments and compliance. This will show that you're not just interested in the job, but that you understand what it entails.
✨Showcase Your Experience
Prepare to discuss your previous experience in regulated environments, particularly in medical devices or pharmaceuticals. Have examples ready that highlight your attention to detail and problem-solving skills, especially when it comes to managing biocompatibility testing and documentation.
✨Communicate Clearly
Since strong communication is key for this role, practice articulating your thoughts clearly and confidently. Be ready to explain complex concepts in a straightforward manner, as you'll need to interact with various stakeholders. Consider doing mock interviews with a friend to refine your delivery.
✨Ask Smart Questions
At the end of the interview, don’t forget to ask insightful questions about the company’s approach to biocompatibility and how they handle regulatory changes. This shows your genuine interest in the role and helps you gauge if the company aligns with your career goals.
