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Quality Assurance Specialist

2 months ago

Pennsylvania, United States Phaidon International Full time

Phaidon International is seeking several Quality Assurance Engineers to enhance our Quality team. The selected Quality Engineers will provide essential support to ensure that all responsibilities and tasks are fulfilled effectively. Below are the key aspects of the role:

Position Title: Quality Assurance Engineer

Work Arrangement: Remote

Contract Duration: Minimum of 6-12 months

Key Responsibilities:

  • Manage Non-Conforming Material Reports (NCMR), including conducting root cause analyses, risk assessments, and historical record evaluations.
  • Perform Complaints Reviews and Manufacturing Analyses, focusing on event assessments and escalation of actions based on findings.
  • Oversee Corrective Action Preventive (CAPA) processes, which encompass root cause investigations and implementation of resolutions.
  • Address Regulatory Requests, ensuring compliance certifications and product inquiries are handled appropriately.
  • Support Manufacturing and Production Lines by collaborating with operations teams to meet value stream objectives.
  • Lead Change Control processes, ensuring documentation change orders comply with quality system requirements.
  • Conduct Validation and Qualification activities, including Installation Qualification and Process Qualification.
  • Manage Deviations, including conducting risk assessments and establishing closure criteria.
  • Implement Risk Management strategies, utilizing Hazard Analysis and Failure Modes and Effects Analysis.

Required Skills and Qualifications:

  • Bachelor's Degree in a relevant field.
  • A minimum of 2 years of experience in Quality Assurance, particularly in complaint processing.
  • Experience in the medical device sector, with knowledge of ISO 13485 and FDA regulations.
  • Ability to independently investigate complaints with minimal supervision.
  • Strong analytical and problem-solving skills, with a proven track record of resolving complex issues.
  • Proficient in technical writing and documentation.
  • Experience with firmware and hardware complaint investigations is advantageous.
  • Meticulous attention to detail and adherence to timelines.
  • Excellent verbal and written communication skills, along with strong interpersonal abilities.
  • Familiarity with MS Word, Excel, Adobe Acrobat, and other standard software applications.
  • Basic understanding of Quality Systems, including CAPA and non-conformances.
  • A collaborative team player with a positive attitude.