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- Tasks: Join our team to ensure high-quality diagnostic solutions in healthcare.
- Company: Genedrive, a leading diagnostics company focused on innovation and quality.
- Benefits: Competitive salary, full-time role, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on collaboration and compliance.
- Why this job: Make a real difference in patient outcomes while working with cutting-edge technology.
- Qualifications: BSc in Biological Science and 2+ years in Quality Assurance.
The predicted salary is between 28000 - 33000 ÂŁ per year.
Join Genedrive as a QA/RA Officer and play a key role in delivering high-quality diagnostic solutions within the clinical and healthcare sector, supporting improved patient outcomes worldwide.
Job Details
- Location: Manchester, M13 9XX
- Full time, permanent position
- Office based
- ÂŁ28,000 - ÂŁ33,000 per year dependent on experience
Please Note: Applicants must be authorised to work in the UK.
Genedrive is a leading diagnostics company operating within the IVD and healthcare sector. The business develops innovative molecular diagnostic solutions that support improved patient outcomes worldwide, with a strong focus on quality, compliance and innovation. Genedrive works closely with global partners, clinicians and laboratories to deliver reliable and impactful products.
About The Role
As QA/RA Officer you will support the Quality Manager by assisting in maintaining an appropriate quality environment for the development and manufacture of products that meet the requirements of European and other Regulators as the company moves towards becoming a leading clinical diagnostics company.
Essential Functions
- Participate fully as a member of the Quality Team within and across the business.
- Provide Quality and Regulatory support to all departments within the business.
- Collaborate with internal and external stakeholders to ensure all our processes comply with the relevant standards and regulations.
- Collate and provide KPI’s, trend data and statistical analysis for Management Review and any other review boards where requested.
- Provide guidance on Risk Management activities.
- Provide guidance, support and maintain the Non-Conformance/Deviation system.
- Provide guidance and perform Root Cause Analysis into CAPA investigations.
- Assist in the review of Technical, Medical Device and Design History Files.
- Create, review, advise and provide guidance on interpretation of SOP’s.
- Review, advise and provide guidance on interpretation of Regulatory requirements.
- Review Verification and Validation Data Reports and SOP’s and provide support during the Validation activities.
- Provide assistance with the maintenance of the electronic and hardcopy record archives.
- Perform internal Audits to a predefined schedule.
- Participate and support in external Inspections and Audits with clients, distributors and Notified Bodies.
- Perform other appropriate duties as assigned.
- Provide support and guidance for new product development projects.
Skills and Qualifications
- BSc in a Biological Science based degree.
- Proven experience (2 years or more) of working in Quality Assurance in the IVD or Medical Device Industry.
- Working knowledge of ISO 13485.
About You
- Attention to detail.
- Organisational and prioritisation skills.
- Strong written and verbal communication skills.
- Problem solving.
- Ability to work alone and as part of a team.
How To Apply For The Role
If you have the skills and experience required for this position, click “apply” today and check your inbox for an email providing more information on how to complete your application and provide any other supporting documents. You must be authorised to work in the UK. No agencies please.
QA/RA Officer employer: Genedrive
Contact Detail:
Genedrive Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA/RA Officer
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching Genedrive and understanding their products and values. Tailor your answers to show how your experience aligns with their mission of improving patient outcomes.
✨Tip Number 3
Practice common interview questions related to QA/RA roles. Think about your past experiences and how they relate to the responsibilities listed in the job description. Confidence is key!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team at Genedrive.
We think you need these skills to ace QA/RA Officer
Some tips for your application 🫡
Read the Job Description Carefully: Before you start writing your application, make sure to read the job description thoroughly. We want to see that you understand what the role of a QA/RA Officer entails and how your skills align with the requirements.
Tailor Your CV and Cover Letter: Don’t just send out the same CV and cover letter for every job. We’re looking for candidates who can show us how their experience in Quality Assurance fits perfectly with our needs at Genedrive. Highlight relevant experiences and skills!
Showcase Your Attention to Detail: As a QA/RA Officer, attention to detail is crucial. Make sure your application is free from typos and errors. We appreciate candidates who take the time to present their information clearly and accurately.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets to us quickly and efficiently. Plus, you’ll receive an email with all the info you need to complete your application!
How to prepare for a job interview at Genedrive
✨Know Your Quality Standards
Familiarise yourself with ISO 13485 and other relevant regulations before the interview. Being able to discuss how these standards apply to the role will show your understanding of the industry and impress the interviewers.
✨Showcase Your Problem-Solving Skills
Prepare examples of past experiences where you successfully identified and resolved quality issues. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewers to follow your thought process.
✨Demonstrate Team Collaboration
As a QA/RA Officer, you'll need to work closely with various departments. Be ready to share instances where you've collaborated effectively with others, highlighting your communication skills and ability to work as part of a team.
✨Ask Insightful Questions
Prepare thoughtful questions about Genedrive's quality processes and future projects. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your career goals.