Advanced Resource Managers
Quality Engineer
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Quality Engineer
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).
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Requirements:
- A minimum of 3 years' Quality Assurance experience within a regulated industry.
- Working knowledge 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, organizational, and stakeholder management skills.
- Degree qualified, or equivalent experience gained within a similar regulated environment.
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Desirable Experience:
- 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).
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