Senior Quality Architect – Drug-Device Combination Products

Phillips Medisize; Cambridge; On-site; GBP 65,000 - 90,000; Full time

Job summary

Phillips Medisize, a Molex company, seeks a Senior Quality Specialist for combination product development. You will guide quality across pharma, devices and drug-device combos from early development to commercialisation, integrating QbD and risk-based approaches.

You will support design controls, risk management, and supplier quality, collaborating with scientists and engineers to ensure robust, compliant products. A customer-focused, proactive quality mindset is essential.

Qualifications

• Provide QA guidance across pharmaceutical, medical device and combination product development programmes.
• Apply GMP, ICH Q8, QbD and Quality Risk Management principles.
• Support design controls, risk management, verification and validation activities.
• Familiarity with regulatory requirements for drug-device combinations.

Responsibilities

• Provide quality guidance and support across development programmes from early development through clinical development and commercialisation.
• Apply GMP principles to development activities, clinical supply manufacture and testing.
• Collaborate with scientists and engineers to integrate quality into products and processes.
• Review deviations, investigations, CAPAs and change controls; support supplier quality management.
• Participate in internal and external quality audits and ensure timely closure of findings.

Skills

Quality assurance

GMP knowledge

Regulatory compliance

Quality by Design

Risk management

Design controls

Cross-functional collaboration

Communication skills

Education

Degree in Pharmaceutical Sciences or Engineering

Tools

ISO 13485

Quality Management Systems (QMS)

Job description

Phillips Medisize, a Molex company, seeks a Senior Quality Specialist for combination product development. You will guide quality across pharma, devices and drug-device combos from early development to commercialisation, integrating QbD and risk-based approaches.

You will support design controls, risk management, and supplier quality, collaborating with scientists and engineers to ensure robust, compliant products. A customer-focused, proactive quality mindset is essential.