Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Priyanka Mahant at email address Priyanka.mahant can be reached on # .
We have Contract role Quality Engineering Analyst / Complaint Investigation Engineer for client at Alameda, CA. Please let me know if you or any of your friends would be interested in this position.
Position Details:
Quality Engineering Analyst / Complaint Investigation Engineer- Alameda, CA
Location : 2601 Harbor Bay Parkway, Alameda, CA 94502 (On-site)
Project Duration: 11 Months of contract
Shift : 8:00 AM - 5:00 PM (Mon-Fri)
Pay Rate : $57.00 per hour on W2
Job Description:
- BA in Sciences. The incumbent will design and maintain a complaint tracking and reporting system; evaluate medical and non-medical complaints and stability investigation requests and make technical judgment on the nature of the problem; evaluate shipping, manufacturing, equipment, validation, engineering project, testing/inspection results, product specifications, employee training records as well as Basic Operating Procedures, SPC/quality trend data, and or stability reports, as applicable, to determine the root causes of the problem.
- The reviewer expert its own judgment based on experience to determine the depth of the investigation required associated the level of risk of non-conformance.
- Maintain a tracking and follow up-system to ensure compliance of Quality Engineering with the FDA Quality Systems Inspection Techniques.
Quality Engineering Analyst (Tracking & Trending)
Position Overview:
- Our client is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment.
- This role is responsible for performing trending investigations, analyzing complaint data, identifying potential product and process issues, supporting root cause investigations, and driving continuous improvement initiatives.
- The individual will collaborate closely with Quality, Operations, Manufacturing, and R&D teams while ensuring compliance with FDA and ISO quality system requirements.
Experience Required:
- 2 to 3 years of experience in a:
- Medical device industry (preferred)
- Pharmaceutical industry
- FDA and/or ISO regulated environment
Required Education:
- Bachelor's Degree in: Biomedical Engineering, or Related Engineering Discipline
Preferred Certifications:
- ASQ Certified Quality Engineer (CQE) or equivalent certification preferred
Required Technical Skills
- Candidates should possess experience in the following areas:
- Quality data analysis and trending investigations
- Complaint handling and complaint trend analysis
- CAPA support and root cause investigation methodologies
- Quality systems within FDA-regulated environments
- Data analysis and reporting using Excel and related analytics tools
- Cross-functional collaboration with Quality, Operations, Manufacturing, and R&D teams
Preferred Qualifications:
- Strong preference for candidates with experience in:
- JMP
- Advanced MS Excel
- SQL querying and data analysis
- Power BI
- Basic to intermediate Python programming
- Quality and complaint management databases
- Dashboard development and data visualization
Key Responsibilities
- Perform complaint tracking and trending activities using quality databases and analytical tools.
- Analyze complaint, CAPA, and quality system data to identify trends, risks, and emerging issues.
- Support root cause investigations and CAPA activities.
- Create dashboards, reports, and data visualizations utilizing Excel, Power BI, JMP, SQL, and Python.
- Partner with Quality, Operations, Manufacturing, and R&D teams to investigate product and process concerns.
- Document investigative findings and support regulatory compliance requirements.
- Assist with continuous improvement initiatives related to complaint handling and quality trending processes.
- Present findings, recommendations, and data-driven insights to stakeholders.
The ideal candidate will have:
- Experience working in a medical device or other highly regulated environment.
- Strong analytical and problem-solving capabilities.
- Experience analyzing complaint and quality data.
- Exposure to CAPA processes and root cause investigations.
- Ability to communicate technical findings clearly to cross-functional stakeholders.
- Proficiency with data analytics and reporting tools.
Interview Process:
Two-Step Interview Process
- Initial Video Interview with Hiring Manager and/or Team Lead
- Panel Interview with Key Stakeholders
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Priyanka Mahant at email address Priyanka.mahant can be reached on # .
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