Quality Assurance Specialist

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

This role supports QA manager to ensure Arthrex Korea meets MFDS requirement for GMP/AER appropriately and pursue the corporate initiatives for QMS and business efficiency.

Essential Duties and Responsibilities:

KGMP Accreditation:

• Maintains the status file of KGMP accredited suppliers/manufacturers to check its expiry date and determine the submission for renewal.
• Assess the change management and proceed with the manufacturing site change/addition along with KGMP application.
• Works with Arthrex Inc. RA, QA and SQA team to collect necessary documents for manufacturing sites for KGMP application.
• For KGMP onsite audit, facilitate the audit by communicating with members at Arthrex Inc. and support auditors by participating onsite audit.

AER and Complaints Handling:

• Review local complaints and FDA MDR cases to assess reportability for AER reporting to MFDS in consultation of QA manager for post market surveillance requirement as required by article 31, Paragraph 1 of the Medical Devices Act and article 51 of the Enforcement Rules of Medical Devices in Korea.
• Involve and take appropriate responsibility in the complains handling process including customer complaints and inter-company complaints (incoming defects) as defined in APAC/Local procedure.

QMS activities:

• Manages QMS documents/records according to document control process defined by APAC/Local procedure. 
• Develop and maintain local SOP as R&R and process based on APAC procedure/Local practice.
• Support eIFU initiative and maintain the documents in accordance with local document control process.
• Maintain Medical Device File if license is created or amended.
• Support QMS roll out by developing the local procedures and supporting internal audits in accordance with APAC strategy for QMS maturity.

Qualification and Requirement:

• 5+ years’ experience as QA/RA representative in medical device company.
• Working experience with comprehensive knowledge of ISO 13485 and Korea MFDS regulation. 
• Working experience on implementing business application projects with scheduled deliverables and process management preferred.
• Effective written and oral communication skills in English & Korean languages
• Ability to interact and collaborate with all levels of cross functional teams on complex projects
• Positive, be proactive, and cooperative personality preferred.
• Ability to work independently in a fast-paced environment and handle multiple tasks and requests.
• Analytical and inquisitiveness over work processes.
• Bachelor’s Degree required, preferably in a Science or Engineering discipline.
• Fluent English preferred.
• Working experience in multi-national medical device company preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.