Senior Quality Assurance Officer
Posted 2 weeks ago by Jackson Hogg
Negotiable
Undetermined
Onsite
Newcastle Upon Tyne, England, United Kingdom
Summary: This temporary 12-month position for maternity cover is for a Senior Quality Assurance Officer within the Quality Assurance and Regulatory Compliance Department in Newcastle-upon-Tyne. The role involves supporting new product development and product lifecycle management, ensuring design assurance, and collaborating with Regulatory Affairs for global submissions. Candidates should have a strong background in IVD medical device quality systems and design controls.
Key Responsibilities:
- Work on site projects to support the progression of commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM).
- Plan, organise and conduct duties related to design assurance, ensuring tasks are delivered within budget and on schedule.
- Collaborate closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s, PMAs, and IVDR CE certifications.
Key Skills:
- 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 21 CFR 820 and ISO 13485.
- Bachelor’s degree in science, medical or technical field.
- Experience with increasing responsibility in medical device Quality Assurance.
- Experience with higher classification IVD/Medical devices and companion diagnostics.
- IVD medical device regulatory affairs experience.
- Experience with the MDSAP Programme.
Salary (Rate): undetermined
City: Newcastle Upon Tyne
Country: United Kingdom
Working Arrangements: on-site
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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