Highlights
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. 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.
Numbers & Facts
| Location | Alameda, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $45–$55.58 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Title: Quality Engineering Analyst (Tracking & Trending)
Location: Alameda, CA 94502
Duration: 12 Months
Position Overview:
Experience Required
Required Education:
Preferred Certifications
Required Technical Skills
Candidates should possess experience in the following areas:
Preferred Qualifications
Strong preference for candidates with experience in:
Key Responsibilities
Ideal Candidate Profile
The ideal candidate will have:
Location: Alameda, CA 94502
Duration: 12 Months
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 Microsoft 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.
Ideal Candidate Profile
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.
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
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