Design Control Engineer

ZipRecruiter; Cambridge; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global Pharmaceutical company in Cambridge seeks a Design Controls Engineer for a 12-month contract. This role involves leading design control and risk management activities for medical device development, ensuring compliance with quality and regulatory standards. Candidates should have a relevant degree or significant experience in a similar role. Apply with your CV to the provided contact email.

Qualifications

• Hold a relevant degree or have proven experience in a similar position.
• Experience in managing design control and risk management.
• Knowledge of compliance with quality and regulatory standards.

Responsibilities

• Lead design control and risk management activities for product development.
• Support documentation compliance with quality and regulatory standards.
• Assist in design validation and audits.

Skills

Knowledge of ISO 13485

Understanding of ISO 14971

Experience with 21 CFR 820

Familiarity with GMP

Education

Relevant degree or proven experience in a similar role

Job description

Overview

CPL Life Sciences are looking to recruit a Design Controls Engineer to join a global Pharmaceutical company based in Cambridge.

This will be a 12 month contract role (PAYE), based on site in Cambridge.

Responsibilities

• Lead design control and risk management activities for medical device combination product development
• Support effective design control and risk management activities internally, at external design companies, and at related manufacturing facilities/CMOs
• Generate and approve documentation, ensuring compliance with quality & regulatory standards (internal & external)
• Provide support to design validation
• Support in internal & external audits where required

Skills & experience

• Hold a relevant degree or proven experience working in a similar role
• Understanding of working to ISO 13485/ISO 14971/21 CFR 820/21 CFR 4, and the EU Medical Devices Regulation.
• Experience in medical device combination products and/or medical devices
• Understand Good Manufacturing Practices (GMP).

Application

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