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Medical Device Quality Expert
3 weeks ago
As a Quality Assurance Specialist, you will play a vital role in driving quality excellence and regulatory compliance within the medical device industry.
Key Responsibilities:- Lead quality improvement initiatives to enhance processes, reduce costs, and ensure regulatory compliance.
- Support change controls, risk assessments, and process validations.
- Analyse data and spot trends using statistical tools.
- Develop and review Corrective Action Preventative Actions (CAPAs), non-conformance reports, and supplier corrective actions.
- Conduct audits and support inspections by regulatory authorities.
- 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 Failure Mode Effects Analysis (FMEAs), root cause analysis, and statistical analysis.
- Excellent attention to detail and problem-solving ability.
- Quality Management
- Communication
- CAPAs
This is an exciting opportunity for a dedicated professional to drive quality excellence and make a meaningful contribution to the success of the organization. The ideal candidate will have a strong understanding of quality principles, excellent analytical and problem-solving skills, and the ability to work effectively in a team environment.
The selected candidate will be responsible for leading quality improvement initiatives, developing and reviewing CAPAs, conducting audits, and supporting inspections. They will also be expected to provide guidance and support to colleagues on quality-related matters.
If you are a motivated and detail-oriented individual with a passion for quality, we encourage you to apply for this exciting opportunity.