Quality Engineer

Advanced Resource Managers Ltd; Fareham; On-site; GBP 42,000 - 62,000; Full time

Job summary

Advanced Resource Managers Ltd is seeking a Quality Engineer to join our medical device client's Distribution function in the UK. The role covers validation, risk management, change control, CAPA and continuous improvement, partnering with Engineering, Operations and Quality teams to stay compliant and audit-ready.

You will support IQ/OQ/PQ validation activities, lead FMEA and risk reviews, manage changes, drive data-driven quality improvements and participate in audits across the supplier and

Qualifications

• Minimum 3 years of Quality Assurance experience in a regulated environment.
• Working knowledge of GMP, ISO 13485 and/or FDA Quality System Regulations.
• Experience writing, executing, reviewing or approving validation protocols and reports.
• Experience with risk management methodologies (FMEA; ISO 14971).
• Experience with CAPA, change control and quality system activities.
• Strong communication, organizational and stakeholder management skills.
• Experience with eQMS and audits (internal, supplier, external).

Responsibilities

• Support validation activities (IQ/OQ/PQ) for processes and equipment.
• Lead and support risk management activities including FMEA updates.
• Ensure changes are controlled via change control processes.
• Drive quality improvements through data analysis and trend monitoring.
• Support new product and process introduction projects.
• Participate in audits (internal, supplier, external).
• Lead CAPA investigations and root-cause analysis.
• Review and approve documentation in the eQMS.

Skills

Quality Assurance

Validation

FMEA

CAPA

QMS

Audits

Lean Six Sigma

Six Sigma

Communication

Stakeholder management

Education

Bachelor's degree or equivalent

Tools

eQMS

Job description

We are working with an established and innovative medical device manufacturer seeking a Quality Engineer to join their Distribution function.

This role offers the opportunity to work across validation, risk management, change control, CAPA and continuous improvement activities, partnering closely with Engineering, Operations and Quality teams to ensure products and processes remain compliant, effective and audit ready.

Key Responsibilities:

• Support process and equipment validation activities, including IQ, OQ and PQ.
• Lead and support risk management activities, including FMEA reviews and updates.
• Ensure changes are effectively managed through established change control processes.
• Drive quality improvements through data analysis and trend monitoring.
• Support new product and process introduction projects.
• Participate in internal, supplier and external audits.
• Lead and support CAPA investigations, root cause analysis and corrective actions.
• Review and approve documentation within the electronic Quality Management System (eQMS).

Requirements:

• A minimum of 3 years' Quality Assurance experience within a regulated industry
• Working kndowledge of GMP, ISO 13485 and/or FDA Quality System Regulations
• Experience writing, executing, reviewing or approving validation protocols and reports
• Knowledge of risk management methodologies, including FMEA and ISO 14971 or similar frameworks
• Experience supporting CAPA, change management and quality system activities
• Strong communication, organisational and stakeholder management skills
• Degree qualified, or equivalent experience gained within a similar regulated environment
• Medical device, pharmaceutical or other highly regulated manufacturing environments
• Contact lens manufacturing and/or distribution operations
• Internal or supplier auditing experience, including completed auditor training
• Lean Manufacturing and/or Six Sigma methodologies
• Experience working within electronic Quality Management Systems (eQMS)