Complaint Specialist
T.
E.
G.
T.
E.
G.
Laguna Niguel, CA Laguna Niguel, CA Contract Contract $30 - $38 an hour $30 - $38 an hour Prestigious billion dollar medical device company targeting a Complaint Specialist to join our fun loving team! Role is temp 3-6 months with possibility to be hired on full time Hybrid schedule, Monday and Thursday onsite Irvine.
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.
Minimum
Qualifications:
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.
Understanding and interpretation of domestic and international complaint handling and reporting requirements required.
Job Type:
Contract Pay:
$30.
00 - $38.
00 per hour Expected hours:
40 per week Shift:
Day shift Weekly day range:
Monday to Friday Work setting:
Hybrid work Application Question(s):
How many years medical device quality complaints experience do you have? Are you proficient ISO 13485? Can you commute to Irvine Mondays and Thursdays? Education:
Bachelor's (Preferred) Ability to Relocate:
Laguna Niguel, CA 92677:
Relocate before starting work (Required) Work Location:
Hybrid remote in Laguna Niguel, CA 92677.
Estimated Salary: $20 to $28 per hour based on qualifications.
E.
G.
T.
E.
G.
Laguna Niguel, CA Laguna Niguel, CA Contract Contract $30 - $38 an hour $30 - $38 an hour Prestigious billion dollar medical device company targeting a Complaint Specialist to join our fun loving team! Role is temp 3-6 months with possibility to be hired on full time Hybrid schedule, Monday and Thursday onsite Irvine.
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.
Minimum
Qualifications:
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.
Understanding and interpretation of domestic and international complaint handling and reporting requirements required.
Job Type:
Contract Pay:
$30.
00 - $38.
00 per hour Expected hours:
40 per week Shift:
Day shift Weekly day range:
Monday to Friday Work setting:
Hybrid work Application Question(s):
How many years medical device quality complaints experience do you have? Are you proficient ISO 13485? Can you commute to Irvine Mondays and Thursdays? Education:
Bachelor's (Preferred) Ability to Relocate:
Laguna Niguel, CA 92677:
Relocate before starting work (Required) Work Location:
Hybrid remote in Laguna Niguel, CA 92677.
Estimated Salary: $20 to $28 per hour based on qualifications.
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