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Quality Assurance Specialist
2 months ago
Role: Quality Assurance Specialist
Location: Remote
Pay Rate: Competitive hourly rate
Work Hours: Flexible schedule
The Quality Assurance Specialist is responsible for ensuring the quality of raw materials, in-process materials, and finished products within a Medical Device Manufacturing environment. The successful candidate will ensure that all materials meet the stringent standards required by regulatory bodies and the company's internal specifications.
Key Responsibilities:
- Quality Control Testing:
- Perform chemical, physical, and microbiological testing on raw materials, in-process materials, and finished products.
- Utilize analytical instruments and techniques as required.
- Accurately document and report all findings, ensuring compliance with company protocols and regulatory requirements.
- Conduct stability testing on products and materials to ensure long-term efficacy and safety.
- Data Analysis and Reporting:
- Analyze test results and compare them against established standards and specifications.
- Prepare detailed reports on findings, highlighting any deviations or non-conformities.
- Assist in the investigation and resolution of quality issues, including root cause analysis and corrective actions.
- Collaboration and Communication:
- Work closely with production teams to ensure quality control processes are integrated into the manufacturing workflow.
- Communicate findings and provide feedback to relevant departments to support continuous improvement initiatives.
- Collaborate with the Quality Assurance team to refine and develop quality control protocols.
- Equipment Maintenance:
- Calibrate and maintain laboratory equipment to ensure accuracy and reliability of test results.
- Report any equipment malfunctions or issues to the appropriate personnel and assist in troubleshooting as needed.
Qualifications:
- Bachelor's degree in Science, Biomedical, Biomechanical, Forensic Science, or a related field.
- Lab-based experience gained through academic studies or internships, including hands-on experience with analytical techniques and instruments.
- Strong understanding of laboratory safety and best practices.
Skills and Competencies:
- Excellent analytical and problem-solving skills.
- Strong attention to detail and a high level of accuracy in work.
- Proficiency in using laboratory instruments and software for data analysis.
- Good communication skills, both written and verbal.
- Ability to work independently as well as part of a team.