Complaint Handling Specialist - California, United States - Noah Medical

Noah Medical California, United States

2 weeks ago

Description

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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