Hybrid Role in San Diego, CA 92122
3 month assignment with potential to extend
Summary
Participate in product quality activities, for complaint investigations of company products. Facilitates cross functional discussions in identifying, documenting, analyzing and reporting quality issues and ensuring that customer feedback is appropriately evaluated. Facilitate functional area initiatives as needed. Provide colleagues support as needed.
Key Responsibilities
- Reviews individual cases, assess for potential adverse events for escalation to Regulatory in a timely manner
- Reviews individual for the evaluation of complaints, including assessment, investigation, containment, for determination of escalation
- Ensures adequacy of complaint records to GMP Standards (e.g. investigations, CAPA, NCs)
- Participates and conducts tasks associated with rotational “monitor” activities of Quality Assurance escalation mailbox
- Facilitates the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
- Participates, facilitates, and/or supports complaint investigations and resulting CAPA activities
- Completes other activities as assigned
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Qualifications Minimum Requirements
- Bachelor's Degree
- 1-3 years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device company
Must Have:
Complaint Handling
Nice To Have:
- Analysis of adverse events and product quality complaints
- Basic understanding of QMS, experience working with QM master data, any experience Around nonconformances and material containment
- Complaint Handling Systems
- Complaint Management
- Complaint Monitoring
- Complaint processing
- Complaints Analysis
Benefits:(employee contribution)
§ Health insurance
§ Health savings account
§ Dental insurance
§ Vision insurance
§ Flexible spending accounts
§ Life insurance
§ Retirement plan
We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
INDTS
Pay: $36.25 - $45.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Work Location: In person
