
Senior Medical Device Quality Assurance Specialist
7 days ago
A seasoned quality assurance professional is sought to lead quality improvement initiatives, enhance processes, and ensure regulatory compliance in a dynamic medical device environment.
Main Responsibilities:- Process Optimization: Develop and implement process improvements to reduce costs, improve efficiency, and maintain regulatory standards.
- Quality Systems Support: Assist in the development, implementation, and maintenance of quality management systems, including change controls, risk assessments, and process validations.
- Data Analysis: Analyze data to identify trends and areas for improvement using statistical tools and techniques.
- Documentation Management: Prepare, review, and maintain CAPAs, non-conformance reports, and supplier corrective actions.
- Audit and Inspection Support: Conduct internal audits and support external inspections by regulatory bodies such as ISO and FDA.
- At least 3 years' experience in a regulated environment, preferably in medical devices or FDA/ISO 13485 certified manufacturing.
- Degree in Quality, Science, or Engineering.
- Strong skills in MS Excel, Word, and PowerPoint.
- Experience with FMEAs, root cause analysis, and statistical analysis.
- Excellent attention to detail and problem-solving ability.
This role offers a unique opportunity to work in a fast-paced medical device industry, developing your skills and expertise while contributing to the success of our organization.
About the Role:This is a 12-month contract position, providing an excellent chance to gain valuable experience and build your network in the industry.
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