P/T Quality Systems Complaints Specialist
orthalign· 300 - RA & QA
About this role
OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Quality Systems Complaints Specialist. The Quality Systems Complaints Specialist determines the legitimacy of complaint feedback and processes complaint files. This role works with cross-functional teams to communicate with customers and coordinate complaint product return. This role also reviews complaint device history records, supports complaint investigation, and contributes to the ongoing improvement of the quality system.
You will:
- Perform initial assessment of customer feedback to determine if the information represents a complaint.
- Support the investigation of returned complaint product and complaints where product was not returned.
- Perform reviews of the complaint device history records.
- Collaborate with Customer Service, Engineering and Operations teams to process complaints in a compliant and timely manner.
- Communicate with customers as applicable, including issuance of closeout letters.
- Develop and maintain product knowledge of existing and new products. Identify, propose, and drive opportunities for improvement, including review and revision of procedures and associated documents.
You need:
- At least 1 year of experience in medical device quality or operations environment
- Strong proficiency using MS Office Suite (e.g., Word, Excel, Outlook)
- Familiarity with medical device regulations ISO 13485, 21CFR820 and complaints
- Strong verbal and written communication skills are essential
- Experience with problem solving and root cause analysis
- Strong interpersonal skills including negotiating and relationship management
- Keen attention to detail and strong organizational skills
- Experience using an electronic quality management system (e.g. - QCBD, EtQ, etc.) and an electronic document management system/PLM (e.g. - Oracle's Agile, Documentum, etc.)
NOTE: We are unable to provide any type of sponsorship at this time.
Frequently Asked Questions
Is the salary disclosed for the P/T Quality Systems Complaints Specialist position at orthalign?
The salary for this P/T Quality Systems Complaints Specialist role at orthalign is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the P/T Quality Systems Complaints Specialist position at orthalign located?
This P/T Quality Systems Complaints Specialist role at orthalign is based in Irvine, California, United States. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the P/T Quality Systems Complaints Specialist role at orthalign full-time or part-time?
This is listed as a PT 60% position. It is posted as a P/T Quality Systems Complaints Specialist role in the 300 - RA & QA department at orthalign.
Which team or department does the P/T Quality Systems Complaints Specialist at orthalign belong to?
This P/T Quality Systems Complaints Specialist position is part of the 300 - RA & QA department at orthalign. See the full job description for more information about the team structure and responsibilities.
How do I apply for the P/T Quality Systems Complaints Specialist position at orthalign?
Click the "Apply Now" button on this page. You will be redirected to orthalign's official application portal hosted on bamboohr where you can submit your application directly.
When was the P/T Quality Systems Complaints Specialist job at orthalign posted?
This P/T Quality Systems Complaints Specialist position at orthalign was posted on Aug 7, 2026. Apply as soon as possible — early applications are often reviewed first.
P/T Quality Systems Complaints Specialist
orthalign
You'll be redirected to orthalign's official application page on bamboohr.