Back to Job SearchWe are recruiting a Quality Engineer to join a leading Pharmaceutical company based in Cambridgeshire. As the Quality Engineer, you will play a crucial role in ensuring the design control and risk management of medical device and combination product development programmes throughout their lifecycle.
Please note this is an initial 12 month contract and hybrid working (2-3 days remote per week).
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Engineer will be varied however the key duties and responsibilities are as follows:
1. As the Quality Engineer, you will lead design control and risk management activities for combination product development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
2. As the Quality Engineer, you will support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
3. As the Quality Engineer, you will ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
4. As the Quality Engineer, you will provide input and support to design validation including, but not limited to, human factors engineering assessments.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Quality Engineer we are looking to identify the following on your profile and past history:
1. Relevant degree in a science or engineering discipline such as chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, or chemical engineering.
2. Proven industry experience with pharmaceutical combination products.
3. A working knowledge and practical experience with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
Key Words: Engineering / Quality Engineer / Medical Device / Combination Product / Design Control / Risk Management / Biotherapeutics / Cambridge / Regulatory Compliance / Human Factors Engineering / ISO 13485
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Please note this is an initial 12 month contract and hybrid working (2-3 days remote per week).
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Engineer will be varied however the key duties and responsibilities are as follows:
1. As the Quality Engineer, you will lead design control and risk management activities for combination product development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
2. As the Quality Engineer, you will support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
3. As the Quality Engineer, you will ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
4. As the Quality Engineer, you will provide input and support to design validation including, but not limited to, human factors engineering assessments.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Quality Engineer we are looking to identify the following on your profile and past history:
1. Relevant degree in a science or engineering discipline such as chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, or chemical engineering.
2. Proven industry experience with pharmaceutical combination products.
3. A working knowledge and practical experience with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
Key Words: Engineering / Quality Engineer / Medical Device / Combination Product / Design Control / Risk Management / Biotherapeutics / Cambridge / Regulatory Compliance / Human Factors Engineering / ISO 13485
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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