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- Tasks: Join us as a QA Specialist, ensuring quality in medical devices and supporting audits.
- Company: Be part of an innovative start-up in regenerative medicine, making a real impact.
- Benefits: Enjoy a hybrid work model with 2-3 days remote and flexible hours.
- Why this job: Gain valuable experience in a growing field while contributing to life-changing products.
- Qualifications: 3+ years in medical devices, ISO 13485, GMP experience, and internal audit skills required.
- Other info: This is a maternity cover position for 9-12 months, with interviews starting soon.
The predicted salary is between 36000 - 60000 £ per year.
QA Specialist – Maternity Cover
An exciting position for a QA Specialist (3+ years experience) to join a start-up Medical Device company (regenerative medicine) for a fixed term contract. This is a 9-12 month maternity cover position and we are beginning interviews next week. The role is Hybrid, 2-3 days remote/2-3 days on site in Nottingham per week.
The Role:
- Supporting the implementation, monitoring and maintenance the QMS in line with requirements of ISO 13485:2016 and 21 CFR Part 820
- Performing internal audits, implementing CAPAs
- Supporting the QARA Director with day to day oversight
- Supporting GMP standards for clinical trial manufacturing
Experience needed:
- Experience within a medical device space (ISO 13485 and 21 CFR Part820)
- Previous GMP experience, particularly useful if prior experience with manufacturing for clinical trials
- QMS and internal audit experience
- Ability to work onsite at least 2 days per week (based just outside of Nottingham)
Interviews will commence w/c 20th January, please apply here or reach out to Alicia Cliff on LinkedIn.
X4 Life Sciences | Quality Assurance Specialist employer: X4 Life Sciences
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land X4 Life Sciences | Quality Assurance Specialist
✨Tip Number 1
Familiarize yourself with ISO 13485:2016 and 21 CFR Part 820. Understanding these standards will not only help you in the interview but also demonstrate your commitment to quality assurance in the medical device industry.
✨Tip Number 2
Highlight any specific experience you have with internal audits and CAPAs. Be ready to discuss how you've implemented these processes in previous roles, as this will be crucial for the position.
✨Tip Number 3
Since the role is hybrid, emphasize your flexibility and ability to work both remotely and onsite. Mention any previous experiences where you successfully managed a hybrid work environment.
✨Tip Number 4
Connect with Alicia Cliff on LinkedIn before the interviews start. A personal touch can make a difference and shows your proactive approach to networking within the industry.
We think you need these skills to ace X4 Life Sciences | Quality Assurance Specialist
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the QA Specialist position. Highlight the key responsibilities and required experiences, such as ISO 13485:2016 and GMP standards, to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in the medical device industry, particularly any roles involving QMS, internal audits, and CAPAs. Use specific examples to demonstrate your expertise in these areas.
Showcase Your Skills: Clearly outline your skills related to quality assurance and regulatory compliance. Mention any relevant certifications or training that align with the requirements of the role, especially those related to ISO standards and clinical trials.
Personalize Your Application: Address your cover letter to Alicia Cliff if possible, and express your enthusiasm for the opportunity. Mention why you are interested in working for a start-up in regenerative medicine and how you can contribute to their goals.
How to prepare for a job interview at X4 Life Sciences
✨Understand ISO Standards
Make sure you have a solid understanding of ISO 13485:2016 and 21 CFR Part 820. Be prepared to discuss how your previous experience aligns with these standards and how you've implemented them in past roles.
✨Showcase Your Audit Experience
Highlight your experience with internal audits and CAPAs. Prepare specific examples of audits you've conducted and how you addressed any findings, as this will demonstrate your hands-on knowledge in quality assurance.
✨Familiarize Yourself with GMP Standards
Since GMP experience is crucial for this role, be ready to talk about your familiarity with Good Manufacturing Practices, especially in the context of clinical trials. Share any relevant experiences that showcase your ability to maintain these standards.
✨Prepare for Hybrid Work Discussion
As the role is hybrid, think about how you can effectively manage your time between remote work and on-site responsibilities. Be ready to discuss your strategies for staying productive and connected with the team while working remotely.
