> Markdown version of [/jobs/ext/3844471-professional-engineering-quality-operations-specialist-i](https://www.wearedevelopers.com/jobs/ext/3844471-professional-engineering-quality-operations-specialist-i). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# Professional - Engineering - Quality Operations Specialist I

- **Company:** Hays Specialist Recruitment LLC
- **Location:** La Cañada Flintridge, CA, United States
- **Experience:** Experienced
- **Salary:** $83,200.0 - $89,357.0
- **Contract:** Contract
- **Skills:** Microsoft Excel, SAP (Applications), Break Fix
- **Published:** October 20, 2026
- **Apply:** https://www.dice.com/job-detail/eb63861c-6774-4f77-8678-90ff0a957df6

## About the Role

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available., Years' Experience: 2-5 years
Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);
Familiarity with medical device complaint files and quality records;
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;
Strong computer skills (including Excel)
Demonstrated written and verbal communication skills
Bachelor's Degree in Electrical Engineering or Mechanical Engineering HIGHLY PREFERRED. Other Engineering degrees or Natural Science degrees to be considered with RELEVANT experience in MEDICAL DEVICE TROUBLESHOOTING

## Description

Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines.
Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Assist complaint intake group through review and verification of initial complaint coding.
Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections. Ensure that appropriate corrective actions are implemented to address the root cause of trending issues.
Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc).
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices