Quality Compliance Engineer

Cpl Life Sciences; Cambridge; On-site; GBP 83,000 - 111,000; Full time

Job summary

A global Pharmaceutical organisation is seeking a Quality & Compliance Engineer for a contract position in Cambridge. The ideal candidate will have significant experience in risk management and design control, especially within medical device development. This role will involve working on combination products, supporting product development from design through to manufacturing, ensuring compliance with quality standards. Interested candidates should apply directly or email their CV.

Qualifications

• Minimum of 5 years of relevant experience in pharmaceutical combination product or device industries.
• Knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.
• Ideally experience in design controls for combination products.
• Familiar with Human Factors Engineering - Usability Engineering.
• Familiar with medical device manufacturing processes.

Responsibilities

• Lead risk management and design control activities for product development.
• Ensure compliance with quality and regulatory standards.
• Support design validation and human factors engineering teams.
• Support design and manufacturing investigations.
• Support internal and external audits from a product development engineering stance.

Skills

Risk management (ISO 14971)

Design control activities

Quality and regulatory compliance

Human Factors Engineering

Medical device manufacturing processes

Education

BSc in appropriate science & engineering discipline

Job description

Overview

Senior Consultant @ Cpl Life Sciences - Contract Engineering UK/EU

Cpl Life Sciences are looking to recruit a Quality & Compliance Engineer to join a global Pharmaceutical organisation based in Cambridge. This role sits within their combination product team - combination product or medical device experience are highly desirable.

This role will provide design control and risk management expertise to medical device and combination product development projects, from initial design through to manufacturing. This role heavily involves generation and review of DHF/risk management files, working alongside device development leads, design engineers and human factors SMEs.

This role is a PAYE contract - with a minimum term of 6 months. You will be expected to be present at the Cambridge site.

Responsibilities

• Lead risk management (ISO 14971) and design control activities.
• Ensure product development activities are compliant with quality and regulatory standards.
• Provide support to design validation/human factors engineering teams.
• Support design and manufacturing investigations.
• Support internal and external audits from a product development engineering stance.

Qualifications

• BSc in appropriate science & engineering discipline with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries
• Knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Ideally experience in design controls for combination products.
• Familiar with Human Factors Engineering - Usability Engineering.
• Familiar with medical device manufacturing processes.

How to apply

If interested, please apply directly or email your CV to [e-mail]