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- Tasks: Support new product development and ensure quality assurance on-site.
- Company: Join a leading company in medical device innovation based in Newcastle-upon-Tyne.
- Benefits: Gain hands-on experience in a dynamic environment with potential for growth.
- Why this job: Be part of impactful projects that shape the future of healthcare technology.
- Qualifications: Bachelor's degree in science or medical field; experience in quality assurance required.
- Other info: This is a temporary 12-month position covering maternity leave.
The predicted salary is between 36000 - 60000 £ per year.
This temporary 12-month position (for maternity cover) reports to the Manager of Quality Assurance (Design) and is part of the Quality Assurance and Regulatory Compliance Department located in Newcastle-upon-Tyne and will be an on-site position.
In this role, you will have the opportunity to:
- Work on site projects to support the progression of the most viable commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM).
- Plan, organise and conduct duties related to design assurance and ensuring executions of tasks ensuring the delivery to the business is within budget and on schedule.
- Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications.
The essential requirements of the job include:
- Working knowledge of design controls for regulated products.
- Experience in IVD medical device new product development and design controls.
- Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820 and ISO 13485.
- Bachelor’s degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance.
It would be a plus if you also possess previous experience in:
- Experienced with higher classification IVD/Medical devices and companion diagnostics.
- IVD medical device regulatory affairs experience a distinct advantage.
- Experience with the MDSAP Programme.
Senior Quality Assurance Officer employer: Jackson Hogg
Contact Detail:
Jackson Hogg Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Assurance Officer
✨Tip Number 1
Familiarise yourself with the latest regulations and standards in IVD medical devices, especially 21 CFR 820 and ISO 13485. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the Quality Assurance and Regulatory Compliance sectors. Attend industry events or join relevant online forums to connect with others who can provide insights or even refer you to opportunities at StudySmarter.
✨Tip Number 3
Prepare to discuss specific projects where you've successfully implemented design controls or managed quality systems. Having concrete examples ready will showcase your experience and problem-solving skills effectively.
✨Tip Number 4
Research StudySmarter's current projects and values. Understanding our mission and how your role as a Senior Quality Assurance Officer fits into our goals will help you articulate why you're a great fit for the team.
We think you need these skills to ace Senior Quality Assurance Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in quality assurance, particularly in IVD medical devices. Emphasise your knowledge of design controls and any specific projects you've worked on that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that directly addresses the key responsibilities and requirements mentioned in the job description. Use specific examples from your past work to demonstrate how you meet these criteria, especially your experience with regulatory submissions and quality systems.
Highlight Relevant Qualifications: In your application, clearly state your educational background and any certifications related to quality assurance and regulatory affairs. Mention your familiarity with standards like 21 CFR 820 and ISO 13485, as these are crucial for the role.
Showcase Soft Skills: Don't forget to mention soft skills that are important for this role, such as teamwork, communication, and problem-solving abilities. These will be essential when working closely with Regulatory Affairs and other departments.
How to prepare for a job interview at Jackson Hogg
✨Showcase Your Technical Knowledge
Make sure to brush up on your understanding of design controls for regulated products and international IVD medical device quality systems. Be prepared to discuss specific examples from your past experience that demonstrate your expertise in these areas.
✨Prepare for Regulatory Questions
Since the role involves working closely with Regulatory Affairs, anticipate questions about global regulatory submissions, such as FDA 510(k)s and PMAs. Familiarise yourself with the processes and be ready to explain how you've navigated similar challenges in previous roles.
✨Demonstrate Project Management Skills
This position requires planning and organising tasks effectively. Prepare to discuss how you have managed projects in the past, ensuring they were delivered on time and within budget. Use specific metrics or outcomes to illustrate your success.
✨Highlight Collaborative Experience
Collaboration is key in this role, especially with cross-functional teams. Be ready to share examples of how you've worked with different departments, particularly in Quality Assurance and Regulatory Affairs, to achieve common goals.
