Job Details
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Job Description
Summary of Position:
- We are looking for a detail-oriented Quality Assurance Specialist to be in charge of all quality assurance activities.
- The Quality Assurance Specialist's responsibilities include developing and implementing quality assurance policies, conducting tests and inspections, identifying production, process, or product issues, and presenting solutions.
- A QA Specialist is responsible for quality assurance audits and ensures product integrity and that standards are being met. A good QA specialist will know how to troubleshoot systems to ensure reliability, usability, and performance.
- To be successful as a Quality Assurance Specialist you should be incredibly thorough and able to help our
- The company maintains the highest quality standards.
Essential Duties and Responsibilities:
- Prepare and implement quality assurance policies and procedures.
- Perform routine inspections and quality audits.
- Identify and resolve workflow and production issues.
- Ensure that standards and safety regulations are observed.
- Address and discuss issues and proposed solutions with superiors.
- Document quality assurance activities and creating audit reports.
- Make recommendations for improvement.
- Create training materials and operating manuals
- Handle Non-Conformity Reports.
- Define root causes in CAPA and NC Reports.
Job Requirements
Qualifications:
- Bachelor Degree (Pharmacy, Science, or Engineer).
- Minimum 2 years’ experience in Medical Device Quality Assurance.
- Working knowledge of tools, methods, and concepts of Quality Assurance.
- Experience with ISO 13485:2016 Requirements.
- Experience with MDD (Medical Device Directive 93/42/EEC as amended by 47/2007).
- Solid Knowledge of Risk Management System (ISO 14971).
Competencies & skills:
- Excellent communication skills, both verbal and written.
- Excellent data collection and analytical skills.
- Strong attention to details
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