Quality Specialist

1 week ago

Costa Mesa, United States T.E.G. Full time

**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 13485
- Understanding and interpretation of domestic and international complaint handling and reporting requirements required.

Pay: $30.00 - $40.00 per hour, overtime eligible

**Job Type**: Contract

Pay: $30.00 - $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 92626 (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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