Quality Engineer

SLS Services Limited; Cambridge; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading medical device company in Cambridge is seeking an experienced professional to lead design control and risk management for medical device development. The role involves overseeing product lifecycle activities and ensuring quality compliance. Ideal candidates will have relevant scientific knowledge and experience in design controls, risk management, and regulatory standards. Willingness to travel as needed.

Qualifications

• Experience in combination product or medical device development, including design controls and risk management.
• Knowledge of ISO 13485, ISO 14971, and 21 CFR 820/4.
• Familiarity with human factors engineering and usability assessments.

Responsibilities

• Lead design control and risk management activities for clinical trials.
• Oversee design validation activities, including usability assessments.
• Collaborate with external partners to ensure compliance.

Skills

Design control

Risk management

Regulatory compliance

Collaboration

Attention to detail

Communication skills

Education

BSc/MSc/PhD in a relevant science or engineering field

Job description

Role Overview:

We are seeking an experienced professional to lead design control and risk management for medical device and combination product development. The role involves overseeing product lifecycle activities, ensuring regulatory and quality compliance, and collaborating with internal teams and external partners to drive safe, effective, and high-quality products.

Key Responsibilities:

• Lead design control and risk management activities to support clinical trials and commercial product approvals.
• Oversee design validation activities, including human factors and usability assessments.
• Collaborate with external design companies, suppliers, and manufacturing partners to ensure quality and regulatory compliance.
• Support investigations, device issue resolution, and continuous improvement initiatives.
• Contribute to regulatory submissions and audits, ensuring alignment with global quality standards.

Requirements:

• BSc/MSc/PhD in a relevant science or engineering field.
• Experience in combination product or medical device development, including design controls and risk management.
• Knowledge of ISO 13485, ISO 14971, 21 CFR 820/4, EU MDR, and GMP.
• Familiarity with human factors engineering, usability assessments, and device manufacturing processes.
• Strong attention to detail, excellent communication skills, and ability to work collaboratively across teams.

Willingness to travel as needed.