Quality Specialist - Costa Mesa, United States - T.E.G.

T.E.G.
T.E.G.
Verified Company
Costa Mesa, United States

4 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Prestigious billion dollar medical device company targeting a Complaint Specialist to join our fantastic team

Role is temp 6-9 months (could be extended)
Hybrid schedule, Monday, Tuesday and Thursday onsite Irvine (Wed and Fri work from home). Start time flex 7am-9am

Comp $30-$40/hr


Must have:


  • Medical Device Class III, or Dental experience
  • Complaint Specialist experience process medical complaints specific to medical device
  • Explain in detail ISO 13485

DUTIES:


  • Evaluates event(s) to determine if it qualifies as a complaint.
  • Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint to appropriate parties as needed.
  • Manages customer relationship and expectations during course of complaint investigation and resolution process.
  • Reviews potential reportable events to determine if regulatory filings are required.
  • Ensures compliance with all federal and international regulations applicable to manufactured medical devices.
  • Maintains and completes complaint files for all customer complaints according to procedures.
  • Maintains awareness of new products and government regulations and requirements.
  • Documents and completes complaints in timely manner.
  • Prepares and submits final customer correspondence as required.
  • Performs other related duties and projects as business needs require at direction of management.

Education and Experience:


  • Bachelor's degree in science, engineering, or equivalent relevant experience preferred.
  • Minimum two (2) years of experience within regulatory affairs or medical device reporting.
  • Medical device experience preferred. ISO 1348
  • Understanding and interpretation of domestic and international complaint handling and reporting requirements required.

Pay:
$ $40.00 per hour
, overtime eligible


Job Type:
Contract


Pay:
$ $40.00 per hour

Expected hours: 40 per week


Benefits:


  • Dental insurance
  • Flexible schedule
  • Health insurance

Experience level:

  • 2 years
  • 3 years
  • 4 years
  • 5 years

Schedule:

  • 8 hour shift
  • Monday to Friday

Work setting:

  • Hybrid work
  • Office

Application Question(s):

  • Are you available for immediate employment and comfortable with a contract position?

Experience:

- complaints: 1 year (preferred)

  • ISO 13485: 1 year (preferred)

Ability to Commute:

  • Costa Mesa, CA required)

Ability to Relocate:

  • Costa Mesa, CA 92626: Relocate before starting work (required)

Work Location:
Hybrid remote in Costa Mesa, CA 92626
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