Quality Assurance Specialist

4 days ago

San Diego, California, United States Wondfo USA Full time
Job Description

Wondfo USA is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring that our medical devices meet the highest quality standards and regulatory requirements.

Key Responsibilities:

  • Support and comply with the company's Quality Management System policies and procedures.
  • Review records for GMP compliance and consistency with company policies and procedures necessary to support customers' quality requirements.
  • Exercise excellent oral and written communication skills; strong attention to detail and record-keeping skills.
  • Perform document control processes ensuring files are accurate and easily retrievable. Serve as a point of contact for document-related inquiries and support.
  • Performing incoming material inspections and releases.
  • Coordinates with the manufacturing department to perform line clearances and in-process verifications as needed.
  • Issues and manages documents for the manufacturing department.
  • Route documents for review and approval in the Document Management System.
  • Approves Document Change Controls and assigns effective dates to documents.
  • Route training records to employees and maintain an internal training log.
  • Aids QA lead and management during internal audits and support external audits and regulatory inspections.
  • Creates and maintains databases for quality assurance and document control as needed.
  • Participates in the implementation of eQMS.
  • Maintain and improve processes to monitor document workflow performance, compliance, and reliability.
  • Participates in investigations for quality events such as NCR, Deviations, and CAPA.
  • Participates in training and development activities to advance core competencies and quality knowledge.
  • Partner with other team members for the records management program.
  • Assist with the development of document templates for various document types.
  • Perform general word processing for various procedures and other document types.
  • Participates in additional projects as assigned by management.

Requirements:

  • Bachelor's degree in science or related field.
  • Minimum of 1-2 years of experience with Quality Assurance in the medical device, biotech or related industry. Working knowledge of ISO 13485 is preferred.
  • Excellent communication and interpersonal skills.
  • Strong problem-solving abilities and attention to detail.
  • Ability to work in a fast-paced and dynamic environment.

Benefits:

  • Competitive Salary
  • PTO /Sick time
  • Paid Holidays
  • 401(K)
  • Medical, Dental and Vision insurance
  • Life Insurance with the option of Voluntary Life Insurance (Buy-Up)
  • Employee Assistance Program

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