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Form of work JOB TITLE: Quality Specialist - Post Market Complaints
**TOP 3 SKILLS:**
- Minimum of 2 years of experience in Quality Assurance with complaint processing role.
- Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
- Problem-solver, good critical thinking skills
LOCATION: Orange County (hybrid -- onsite 2-3x/week)
DURATION: 6 month contract (likely to extend or convert)
RATE RANGE: $40-50/hr
SUMMARY:
The QA Specialist - Post Market supports the growth and continuous improvement of the Complaint Quality System, providing hands-on support to ensure complaints are reviewed and assessed in a timely manner. Duties include, but are not limited to, day to day complaint review, investigation reports, adverse event reporting and complaints log and trend maintenance. This role is hybrid and includes regular on-site laboratory work.
RESPONSIBILITIES:
- Evaluates complaints to determine complaint investigation, Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.
- Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
- Evaluate all information from a technical perspective to ensure appropriate Analysis and Investigation
- Reviews daily processes to ensure issues are being addressed and escalated in a timely manner
- Maintains complaints log
- Participates in process improvements
- Perform other quality and regulatory-related duties as assigned
QUALIFICATIONS:
- Bachelor's Degree
- Minimum of 2 years of experience in Quality Assurance with complaint processing role.
- Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
- Strong problem-solving skills, critical-thinker, and experienced at investigating and resolving complex issues
- Understand basic principles of good technical writing skills
- Must work across functional teams within the organization
- Attention to detail and timeliness are critical
- Excellent communication (verbal and written) and interpersonal skills required
- Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems
- Basic statistical methods including trend analysis
- Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
- Must be able to work under minimum supervision and in a team environment.
- Must be a positive and energetic team player
- Must be able to work from home or hybrid (remote/at site)
- Experience with software/firmware related complaints a plus.
IND123
