Quality Engineer — Medical Devices & Combo Products

Hyper Recruitment Solutions; Cambridgeshire and Peterborough; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading recruitment agency is seeking a Quality Engineer for a pharmaceutical company in Cambridge. The role involves leading design control and risk management for combination products, ensuring regulatory compliance, and providing input to design validation. Ideal candidates will have relevant degrees and experience in medical devices or pharmaceuticals. Join this dynamic team in a full-time position, contributing to high-quality standards in healthcare.

Qualifications

• Proven industry experience in the pharmaceutical combination product and/or medical device industries.
• Working knowledge and practical experience with relevant regulatory standards.

Responsibilities

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

Skills

Design control

Risk management

ISO 13485

ISO 14971

21 CFR 820

21 CFR 4

Regulatory compliance

Education

Relevant degree in a science or engineering discipline

Job description

A leading recruitment agency is seeking a Quality Engineer for a pharmaceutical company in Cambridge. The role involves leading design control and risk management for combination products, ensuring regulatory compliance, and providing input to design validation. Ideal candidates will have relevant degrees and experience in medical devices or pharmaceuticals. Join this dynamic team in a full-time position, contributing to high-quality standards in healthcare.