Topcon Healthcare is seeking a Quality Assurance Specialist to support investigations into quality issues, CAPA, and compliance with regulatory standards. The ideal candidate will be detail-oriented with strong analytical skills and effective communication, contributing to the continuous improvement of the company's quality management systems
Job Summary
The Quality Assurance Specialist leads and provides support to investigations involving Complaints, Corrective and Preventive Actions (CAPA), and nonconformance to ensure our processes meet regulatory and Quality Management System requirements.
Responsibilities include analyzing and investigating reported quality issues, maintaining and analyzing problem logs to identify trending issues, and issuing Supplier Corrective Action Requests.
Topcon offers a comprehensive benefit package including medical, dental, vision, life insurance, disability insurance, tax saving spending accounts, a 401(k) plan with employer match, and tuition reimbursement.
Matching Summary
Match Score: 85
Topcon Healthcare is seeking a Quality Assurance Specialist to support investigations into quality issues, CAPA, and compliance with regulatory standards. The ideal candidate will be detail-oriented with strong analytical skills and effective communication, contributing to the continuous improvement of the company's quality management systems.
Salary
$60,000 to $80,000 Annualized
Skills & Requirements
Must-have
Investigate quality issues
Analyze problem logs
Issue Supplier Corrective Action Requests
Coordinate Supplier Qualification
Update Quality Management System procedures
Resolve complaints and CAPA
Nice-to-have
Detailed-oriented
Effective communication
Strong analytical skills
Cross-functional collaboration
Continuous improvement mindset
Key Requirements
Bachelor or higher degree in science or related field
2+ years experience in a regulated manufacturing environment
Familiarity with FDA QSR and ISO Requirements
Detail-oriented with good analytical ability and problem-solving skills
Ability to work independently and efficiently and work well with others
Good organizational and communication skills (verbal and written)
Ability to follow detailed written procedures; handle multiple tasks simultaneously and prioritize accordingly