QA Specialist I

QA Specialist I

Summary

The QA Specialist works as part of the quality and regulatory team at OriGen Biomedical. The position provides quality guidance, monitoring and administrative support to ensure continuous compliance with domestic and international regulatory requirements and standards.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Creating, revising, and approving documents and records related to quality system activities.

  • Maintaining the electronic quality management software,

  • Creating and maintaining product labels,

  • Review and disposition of manufacturing records,

  • Review of analytical documents, including raw material and final product analysis,

  • Supporting root cause analysis investigations, corrective/preventive action planning, and conducting effectiveness checks.

  • Maintaining Design History Files (DHF), design dossiers, and technical files following product approval,

  • Maintaining company metrics and compiling reports,

  • Perform routine internal audits, identify and implement process improvements,

  • Support training for new employees, new or revised documents and processes,

  • Participate in inspections/audits by the notified body or other international regulatory agencies by producing requested documents or answering inquiries for information,

  • As needed, perform incoming and final product inspection, perform equipment calibrations, process product returns, execute test plans for process validation,

  • Related duties, and special projects as assigned.

Competencies

  • Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives with limited supervision.

  • Proven skills in root cause analysis and corrective action planning.

  • Personal leadership skills and fosters working in a team environment.

  • Works cross functionally to complete projects and testing.

  • Exercises judgment within broadly defined practices and policies.

  • Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel.

  • Outstanding communication skills, both written and oral; expected to communicate directly with project managers, client auditors, senior management and regulatory inspectors.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job periodically operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. In some cases, additional work hours may be required.

Required Education and Experience

  • BS/BA Degree or equivalent in life science or engineering field

  • Minimum of 5 years' experience in medical device manufacturing environment

  • Clear understanding of ISO 13485:2003 and/or ISO 13485:2016 

  • Clear understanding of medical device quality management systems

  • Clear understanding of Good Documentation Practices, Good Manufacturing Practices

  • Skilled in conducting root cause analysis, CAPA, and verification of effectiveness

  • Skilled in managing nonconforming materials, associated reports, and evaluating supplier corrective actions

  • Internal audit training a plus

Preferred Education and Experience

Developing test plans for process validation.

Evaluating design history files 

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.