Quality Engineer

Fareham Source: WhatJobs

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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)