Quality Engineer in Cambridgeshire

Energy Jobline CVL; England; Hybrid; GBP 40,000 - 55,000; Full time

Job summary

A leading Pharmaceutical Company in Cambridgeshire is seeking a Quality Engineer for an initial 12-month contract. This role involves leading design control and risk management activities, ensuring compliance with quality standards, and providing expertise for medical device development. Hybrid working is available, with 50% on-site requirements. Ideal candidates have relevant science or engineering degrees and industry experience in pharmaceutical combination products.

Qualifications

• Proven industry experience in the pharmaceutical combination product and/or device industries.
• Working knowledge and practical experience with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.

Responsibilities

• Lead design control and risk management activities for combination product development programmes.
• Ensure combination product development activities are compliant with quality and regulatory standards.
• Provide input and support to design validation including human factors engineering assessments.

Skills

Design Control

Risk Management

Medical Device

Combination Product

Regulatory Compliance

Education

Relevant degree in a science or engineering discipline

Job description

Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide.

We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.

Our client, a leading Pharmaceutical Company in Cambridgeshire, is seeking a Quality Engineer to join their team on an initial 12 month contract. As the Quality Engineer, you will be responsible for providing subject matter expertise to medical device and combination product development programmes throughout the product lifecycle. This role offers hybrid working (50% onsite).

Key Duties and Responsibilities:

• 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.
• Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
• Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
• Provide input and support to design validation including, but not limited to, human factors engineering assessments.

Role Requirements:

• Relevant degree in a science or engineering discipline such as chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, or chemical engineering.
• Proven industry experience in the pharmaceutical combination product and/or device industries.
• 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:

• Design Control
• Risk Management
• Medical Device
• Combination Product
• Pharmaceutical
• Cambridge
• Quality Standards
• Regulatory Compliance
• Human Factors Engineering

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.

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.