Quality Engineer

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

Join a global medical device organisation where quality is at the heart of innovation and patient care. This role offers the opportunity to work across the full product lifecycle, supporting quality systems, manufacturing processes, risk management activities, and continuous improvement initiatives that help ensure safe, effective products reach patients worldwide.

Working closely with cross-functional teams, you will play a key role in driving product and process quality, investigating non-conformances, leading CAPA activities, and supporting validation and regulatory compliance efforts. You’ll have the opportunity to make a tangible impact, using data-driven insights and problem-solving skills to enhance quality performance and operational effectiveness.

This position would suit a proactive quality professional with experience in a regulated medical device environment who is passionate about delivering high standards, improving processes, and contributing to products that genuinely improve patient outcomes.

Key Skills & Experience:

• Experience working within a regulated medical device, pharmaceutical, or healthcare manufacturing environment
• Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements
• Experience with CAPA, non-conformance investigations, and root cause analysis methodologies
• 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
• Strong communication skills with the ability to work effectively across cross-functional teams