Complaint Handling Specialist

1 month ago

California, United States Noah Medical Full time

About The Team

The Quality Engineer 1 reports to the Manager of Complaints and Post-Market . This position provides support and ownership to document control processes, training, and complaints. We are looking for someone that is highly motivated. The candidate must be a self-starter, team builder, and excellent communicator.

A Day In The Life Of Our Complaint Handling Specialist:

  • Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
  • Review customer feedback and service reports for potential complaints
  • Evaluate complaints for potential adverse events and vigilance reporting decisions
  • Review the complaint file to ensure all complaint elements, including product investigations, have been addressed and properly documented within the complaint file
  • Perform routine complaint trending and measure against statistical trend limits and/or pre-determined action limits
  • Support product investigation activities as needed
  • Initiate risk file updates based on post market data such as complaint rates and new hazards
  • Process change orders in the ePLM system as needed.
  • Assist in audits (internal and external), may also conduct internal audits as needed.
  • Conduct training and manage assignment of training as needed.
  • Support CAPA activities as needed.
  • Other QMS activities as assigned.

About You:

  • AS (BS preferred) in Mechanical, Industrial, Electrical Engineering or Technology, Life Sciences, or related fields.
  • Minimum of 0-2 years work experience in quality within the medical device industry or 0 years with a masters degree (MS) or doctorate degree (PhD) in engineering or science.
  • Certifications such as ASQ CQE, CQA, CBA, CSSBB are a plus
  • Understanding of medical device quality processes governed by 21CFR820, ISO 13485, MDD/MDR is a plus.
  • Experienced in Microsoft Office, Google Suite and ePLM/eQMS systems.
  • Be a self-starter, team builder, excellent in communication skills (written and verbal), detail oriented, organized, and able to prioritize and balance workload in a fast-paced start-up environment.
  • Ability to support cross functional teams
  • Demonstrate solid background of technical knowledge and experience.

Workplace Type: Hybrid

Benefits & Perks (For Full Time Employees):

  • Competitive Salary
  • Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
  • Equity & Bonus Program
  • Life Insurance (company paid & supplemental) and Disability insurance
  • Mental health support through medical insurance programs
  • Legal and Pet Insurance
  • 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days
  • Paid parental leave
  • In-office snacks and beverages
  • In-office lunch stipend
  • Learning & Development Opportunities: On-demand online training and book reimbursement
  • Team building and company organized social and celebration events

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