We are seeking a skilled Quality Engineer to join our team in a regulated environment.
This is an exciting opportunity for someone with experience in medical devices or FDA/ISO 13485 certified manufacturing who wants to expand their skills and work on high-profile projects.
As a Quality Engineer, your key responsibilities will include:
* Leading quality improvement initiatives to enhance processes and ensure regulatory compliance
* Supporting change controls, risk assessments, and process validations
* Analysing data and spotting trends using statistical tools
* Writing and reviewing CAPAs, non-conformance reports, and supplier corrective actions
* Conducting audits and supporting inspections by ISO and FDA regulators
To be successful in this role, you will need:
* 3+ years' experience in a regulated environment - ideally medical devices or FDA/ISO 13485 certified manufacturing
* Degree in Quality, Science, or Engineering
* Strong MS Excel, Word, and PowerPoint skills
* Experience with FMEAs, root cause analysis, and statistical analysis
* Excellent attention to detail and problem-solving ability
This is a fantastic opportunity for a motivated and experienced quality professional to take their career to the next level.
Key aspects of this role include:
1. Quality Improvement: Lead initiatives to enhance processes and ensure regulatory compliance
2. Change Management: Support change controls, risk assessments, and process validations
3. Data Analysis: Analyse data and spot trends using statistical tools
4. Documentation: Write and review CAPAs, non-conformance reports, and supplier corrective actions
5. Auditing: Conduct audits and support inspections by ISO and FDA regulators
This is an excellent chance to grow professionally and develop valuable expertise in quality management.