Quality Engineer: Drive Medical Device Quality & Impact

Planet Pharma; Newbridge; On-site; GBP 50,000 - 80,000; Full time

Job summary

Planet Pharma is seeking a proactive quality professional to join a global medical device organisation. You will support quality systems, manufacturing processes, risk management, and continuous improvement initiatives that ensure safe, effective products reach patients worldwide.

You will collaborate with cross-functional teams to drive product and process quality, investigate non-conformances, lead CAPA activities, and support validation and regulatory compliance efforts.

Qualifications

• Experience in a regulated medical device, pharmaceutical, or healthcare manufacturing environment.
• Strong knowledge of Quality Management Systems (QMS) and regulatory requirements.
• Experience with CAPA, non-conformance investigations, and root cause analysis.
• Understanding of risk management principles and ISO 14971.
• Exposure to process validation activities including IQ/OQ/PQ.
• Experience supporting audits and regulatory inspections.
• Ability to analyse quality data and identify improvement opportunities.
• Knowledge of Lean, Six Sigma, or continuous improvement methodologies.

Responsibilities

• Support quality systems, manufacturing processes, and risk management across the full product lifecycle.
• Investigate non-conformances, lead CAPA activities, and support validation and regulatory compliance efforts.
• Drive data-driven quality improvements and operate across cross-functional teams.
• Contribute to continuous improvement initiatives that enhance product quality and patient outcomes.

Skills

QMS knowledge

CAPA

Root cause analysis

ISO 14971

IQ/OQ/PQ

Audits & inspections

Quality data analysis

Lean / Six Sigma

Cross-functional teamwork

Job description

Planet Pharma is seeking a proactive quality professional to join a global medical device organisation. You will support quality systems, manufacturing processes, risk management, and continuous improvement initiatives that ensure safe, effective products reach patients worldwide.

You will collaborate with cross-functional teams to drive product and process quality, investigate non-conformances, lead CAPA activities, and support validation and regulatory compliance efforts.