Quality Engineer I
LanceSoft Inc
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.
Vacancy posted 3 days ago
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