QA/RA Supervisor

Job Summary:

Be responsible for implementation, maintenance and improvement of (Amsino International Inc.-Pomona office) Company’s Quality management systems to ensure packaging, labeling, storage and distribution of safe, effective and reliable medical devices in compliance with requirements of ISO13485, FDA, MDD and other applicable domestic and international regulations, standards and guidance.

Summary of Essential Job Functions:

Implementation, maintenance and improvement of Quality Management System

  • Implementation, maintenance of ISO13485 and related SOPs
  • Write, co-write, review and approve the Pomona SOPs
  • Participation in preparation of strategic quality plans, and management review
  • Organize the internal audits and keep the related records
  • Prepare and coordinate with Corporate for third party audit (eg. TUV)
  • Assurance of quality records

Assurance of packaging, labeling, storage and distribution

  • Co-management of non-conforming material/device process
  • Co-management of return material/device authorization and disposition
  • Communications between customers and internal departments in terms of the quality issues
  • Control 3PL warehouse compliance

Complaint Handling

  • Process all branded incoming complaints from end users and customers through SharePoint
  • Follow-up with complaint case owners for investigations/responses
  • Create and submit complaint closure letters to customers
  • Maintain Complaint log spreadsheet
  • Track complaint rates

Returns (RGA)

  • Perform inspection of returned or damaged products
  • Responsible for product dispositioning and recording
  • Request complaint product RGAs
  • Organize complaint credits and debits
  • Inspect complaint samples and forward to complaint case owners

Regulatory compliance

  • Co-ordinate the MDR, Canadian MD reporting, Vigilance system

Management of packaging, labeling, storage and distribution

  • Manage label and labeling compliance as per 21 CFR Part 801 and related guidance
  • Manage the non-conforming process

Perform other assignment as necessary

Minimum Requirements

  • BS or above in regulatory administration, bio-science, life science, engineering or technical discipline
  • 5+ years of experience with broad responsibility of quality management system, regulatory compliance of medical industry, disposable medical device is preferable.

Skill requirements

  • Strong knowledge in ISO13485 standard, FDA medical devices regulations and MDD; statistical analysis is preferable
  • Experience of FDA, ISO13485 audit and or other domestic/international regulatory agencies’ inspection
  • Strong interpersonal skills, verbal and written communication skills
  • Self-development, organizing and prioritizing tasks
  • Bilingual is preferable (Chinese, English)
  • Good team work spirit