QA Analyst working on testing strategy for internal applications at Focus Group. Collaborating closely with development team to ensure product quality and stability.
About the role
- QA Specialist responsible for managing quality assurance systems at Cook Medical Korea. Implementing quality improvement initiatives and coordinating audits complying with regulations.
Responsibilities
- Implement continuous quality improvement initiatives in line with MFDS regulation and all regulatory requirements relevant to sales of Cook products
- Coordinate activities to direct, control and maintain the company’s accreditations (e.g.Korean GMP, Ad-hoc audits)
- Disseminate quality assurance trends and information to key CMK RAQA Manager to ensure the organization is up to date with current quality requirements
- Maintain and update internal quality documents in a timely manner.
- Recall & Complaint handling of Cook products and report local & overseas adverse event to MFDS in cooperation with RA, Sales, Overseas manufacturer, Supply chain.
- Arrange local distributor audit and follow up on audit findings in cooperation with stakeholders.
- Sop authoring
- Auditing / Audit response writing
- CAPAs /NCs/Deviations
Requirements
- Bachelor’s degrees in science, medicine and medical science preferred
- Preferably at least 1 years of QA experience in medical device or pharmaceutical of multinational companies
- GMP Experience in audit& inspection preferred
- Relevant territory qualifications (e.g. science, engineering, pharma)
- Organized, good management and planning skills
- Ability to work closely with people at all levels
- Excellent communication skills
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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