Job Description
HonorVet Technologies (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations. Our dedicated recruitment team focuses on delivering qualified life sciences and pharmaceutical professionals efficiently while ensuring quality, compliance, and client satisfaction.
Job Title: Quality Operations Specialist I
Location: Irvine, CA
Contract Length: 12 months with potential extension
Major Accountabilities:
Job Title: Quality Operations Specialist I
Location: Irvine, CA
Contract Length: 12 months with potential extension
Major Accountabilities:
- 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
- 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.
Numbers & Facts
| Location | Irvine, CA |
| Industry | Staffing/Employment Agencies |
| Company Size | 50 to 99 employees |
| Year Founded | 2015 |
| Website | http://www.honorvettech.com |
Benefits
401K, Employee Referral Program, Life Insurance
About Company
Is a leading Service Disabled Veteran Owned Small Business providing IT, Telecom and Medical Staffing.
Skills
- Assembly Lineunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Clinical Researchunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Computer Skillsunmatched
- Consultingunmatched
- Contract Research Organization (CRO)unmatched
- Corporate Complianceunmatched
- Corrective Actionunmatched
- Cross-Functionalunmatched
- Customer Satisfactionunmatched
- Electrical Engineeringunmatched
- FDA (Food and Drug Administration)unmatched
- FDA Requirementsunmatched
- Financeunmatched
- ISO (International Organization for Standardization)unmatched
- Identify Issuesunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Market Trackingunmatched
- Mechanical Engineeringunmatched
- Medical Affairsunmatched
- Medical Equipmentunmatched
- Medical Recordsunmatched
- Natural Scienceunmatched
- Performance Analysisunmatched
- Pharmacovigilanceunmatched
- Presentation/Verbal Skillsunmatched
- Procedure Developmentunmatched
- Process Improvementunmatched
- Process Managementunmatched
- Product Supportunmatched
- Product Testingunmatched
- Quality Assuranceunmatched
- Quality Controlunmatched
- Regulationsunmatched
- Regulatory Reportsunmatched
- Regulatory Requirementsunmatched
- Research & Development (R&D)unmatched
- Research Laboratoryunmatched
- SAPunmatched
- Staff Requirementsunmatched
- Supply Chainunmatched
- Technical Writingunmatched
- Trend Analysisunmatched
- Writing Skillsunmatched
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