• The Quality Assurance Manager is responsible for assuring compliance with Topcon Healthcare Solutions, Inc. internal procedures and state, federal and international regulations as applicable. The focus of this position includes but is not limited to managing QA team members, processing complaints and Corrective and Preventive Actions (CAPA), implementing and managing quality improvement projects, and statistical analysis for the advancement of overall quality improvement.
Core Job Duties:
• General management of QA department activities and team members.
• Assist with management of Topcon Healthcare Solutions (THS) ISO13485 / FDA CFR 21 based quality system.
• Conduct internal quality audits to insure compliance to regulatory requirements.
• Oversee quality compliance and product compliance at OEM, outsource facilities.
• Review new product designs and product design changes for potential Quality related issues and Regulatory notifications/submissions (e.g. 510(k), PMA, MDD, CE-Mark).
• Management of THS Complaint handling, Corrective and Preventive Action (CAPA), and SCAR (Supplier Corrective Action Request) processes.
• Provide assistance during periodic external quality system audits performed by FDA, Japan MHLW, ISO Notified Body, and customers.
Provide support for any required regulatory reports to the FDA and ISO Notified Body.
Minimum Job Requirements:
Education & Experience:
• 6+ years of experience in related Quality Assurance position within a medical industry company.
• BS or higher in related Pharmaceutical, Life Science or Engineering discipline.
• Demonstrated knowledge of FDA 21 CFR 820.
• ISO 13485 experience preferred.
• Experience in implementation and administration of quality systems for medical manufacturing and quality control operations.
Knowledge, Skills, and Abilities:
• Ability to provide leadership to peers, and drive change and improvement in quality programs throughout the organization
• MS Office proficiency.
• Advanced organizational skills with the ability to handle multiple assignments.
• Management experience preferred.
• Self-motivated, possess excellent written and oral communication skills, and ability to interact with all levels of management and staff.
• Demonstrated track record of achievement.
• Ability to work independently.
• Ability to work smart in a fast-paced environment.
• Ability to think proactively and plan and execute resourcefully.
• Ability to coordinate team activities.
• Strong knowledge of creation of technical documentation.