Job Description
Title: Quality Engineer I
Location: Pleasanton, CA 94588
Duration: 12 Months
Description:
Key Responsibilities
Required Qualifications
Preferred Qualifications
Location: Pleasanton, CA 94588
Duration: 12 Months
Description:
- This position is NonExempt. Hours over 40 will be paid at Time and a Half.
- This position is responsible for providing quality system support, including quality metrics support, audit readiness, and other duties related to the maintenance and improvement of the quality system.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO 13485, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- 0-3 years exp - supports the design, manufacturing, and maintenance of safe, compliant medical devices.
- This role assists senior engineers with validation activities, quality documentation, and problem solving in a highly regulated environment governed by FDA 21 CFR 820, ISO 13485, and ISO 14971.
Key Responsibilities
- Support validation activities Assist in equipment, process, and software validation (including CSV), troubleshoot discrepancies, and help plan validation efforts using risk based approaches.
- Document quality issues Prepare, review, and maintain quality control documents, reports, and production records.
- Participate in CAPA investigations Support root cause analysis and corrective/preventive actions under supervision.
- Assist with nonconformance management Help evaluate product defects, deviations, and material review board (MRB) activities.
- Perform data analysis Collect and analyze quality metrics to identify trends and improvement opportunities.
- Support audits and inspections Prepare documentation and participate in internal audits and external regulatory inspections.
- Ensure compliance Follow established procedures and quality standards in a regulated environment (pharma, biotech, or medical device).
- Collaborate cross functionally Work with R&D, manufacturing, and supplier teams to address quality issues and support continuous improvement.
Required Qualifications
- Bachelor s degree in Engineering, Biomedical Engineering, Quality Engineering, or related field.
- Understanding of FDA QSR, ISO 13485, and basic risk management principles.
- Strong attention to detail, integrity, and accountability in documentation and compliance.
- Ability to interpret technical drawings, procedures, and test methods.
- Proficiency with MS Office and basic statistical tools.
Preferred Qualifications
- Internship or co op experience in medical device, biotech, or regulated manufacturing.
- Familiarity with validation lifecycle, root cause analysis tools, and CAPA systems.
- Knowledge of cleanroom or GMP environments.
Numbers & Facts
| Location | Pleasanton, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $30 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
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.