Quality Engineer II: CAPA, Risk & Process Improvement

Lancesoft; Fremont (CA); On-site; USD 47,000 - 55,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

401k

Critical Illness Insurance

Life Insurance

Accident Insurance

Job summary

LanceSoft is seeking a Quality Engineer II in Fremont, CA to provide day-to-day QE support for product and process quality improvements, including risk assessments, CAPA, and change controls in a regulated manufacturing environment.

The role requires knowledge of cGMP/ISO 13485, experience with root-cause analysis, DFMEA/PFMEA, and strong documentation skills; you will lead investigations and drive continuous improvement on the floor and through quality systems.

Qualifications

• Education Bachelor's degree in Engineering, Chemistry, Biology, Biotechnology, Life Sciences or related field.
• Advanced degree may substitute for part of experience.
• 2–5 years QE/QA experience in a regulated industry highly preferred.

Responsibilities

• Lead investigations of nonconformances, deviations and quality events.
• Perform risk assessments and support containment and disposition decisions.
• Apply structured root-cause analysis (8D, Fishbone, 5-Why) and develop corrective actions.
• Support CAPA, change-control and risk-management activities.
• Ensure investigations are documented and timely; monitor trends for systemic action.
• Provide QE input for product design, validation/qualification, and lifecycle changes.

Skills

cGMP knowledge

Root-cause analysis

DFMEA/PFMEA

Quality data analysis

Technical writing

Cross-functional

Statistical methods

Problem solving

Education

Bachelor's degree in Engineering/Science

Advanced degree may substitute

Tools

MasterControl

Oracle

MS Office

Job description

LanceSoft is seeking a Quality Engineer II in Fremont, CA to provide day-to-day QE support for product and process quality improvements, including risk assessments, CAPA, and change controls in a regulated manufacturing environment.

The role requires knowledge of cGMP/ISO 13485, experience with root-cause analysis, DFMEA/PFMEA, and strong documentation skills; you will lead investigations and drive continuous improvement on the floor and through quality systems.