Quality Engineer

Hyper Recruitment Solutions; United Kingdom; Hybrid; GBP 40,000 - 55,000; Full time

Job summary

A leading Pharmaceutical Company in the United Kingdom is seeking a Quality Engineer to lead design control and risk management for combination product development. This role requires a relevant degree and proven experience in the pharmaceutical sector. The successful candidate will ensure compliance with quality standards and support design validation with a hybrid working model.

Qualifications

• Relevant degree in 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 quality management systems.

Responsibilities

• Lead design control and risk management activities for product development.
• Support risk management activities at external design companies.
• Ensure compliance with quality and regulatory standards.
• Provide input to design validation including human factors assessments.

Skills

Design Control

Risk Management

Quality Standards

Regulatory Compliance

Human Factors Engineering

Education

Relevant degree in a science or engineering discipline

Tools

ISO 13485

ISO 14971

21 CFR 820

21 CFR 4

EU Medical Devices Regulation

Job description

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

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 programs, 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 in the pharmaceutical combination product and/or device industries.
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:
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.