Join a leading organisation within the medical device manufacturing sector as a Quality Assurance Specialist.
This role is responsible for supporting quality management systems, ensuring regulatory compliance, and driving continuous improvement initiatives. This opportunity is ideal for professionals with experience in quality assurance, medical device manufacturing, ISO 13485 compliance, CAPA management, and regulatory quality systems.
What You’ll Be Doing:
- Manage the review cycle for customer complaints and Corrective and Preventive Actions (CAPAs).
- Lead and coordinate the internal audit programme.
- Maintain and improve quality management system processes and documentation.
- Support document control activities, including SOP creation, revision, and approval workflows.
- Facilitate nonconformance investigations and root cause analysis activities.
- Ensure timely implementation and verification of corrective actions.
- Support compliance with ISO 13485, FDA regulations, and applicable quality standards.
- Assist with quality inspections, documentation reviews, and production support activities.
- Monitor quality performance metrics and identify opportunities for continuous improvement.
- Deliver quality assurance training programmes alongside the Quality Manager.
- Support change control processes and controlled document management.
- Collaborate with cross-functional teams to maintain product quality and regulatory compliance.
What We’re Looking For:
- Previous experience within the moving or relocation industry is required.
- Associate degree or equivalent combination of education and experience.
- 3–5 years of quality assurance experience within medical device manufacturing.
- Strong knowledge of ISO 13485, FDA regulations, CAPA, audits, and quality systems.
- Excellent written and verbal communication skills with the ability to prepare reports and procedures.
- Proficiency in Microsoft Word, Excel, Outlook, and quality management software systems.
Interested? Reach out to Alchemy Global Talent Solutions today.