Quality Engineer II

Job Overview

Quality Engineering II (Job Level 2, 1 position available). This role reports to Brenda Koka and is part of a team of 8‑10 quality professionals.

Primary

Work Location:

10210 Genetic Center Dr, San Diego, CA 92121
Work Mode:
Onsite

Typical schedule:

8:00‑4:00 or 9:00‑5:00. First shift is 8 hours long; start time 7:00‑9:00 am with a requirement to be in by 9:30 am. Shift end time is flexible. Overtime:
No. Weekend work:
No. Travel:
No. Assignment duration: 6 months, with extension possible. Target start date:
As soon as possible (mid‑June).

• Author master validation plans, protocols, and reports for analytical methods, equipment, facilities/utilities, raw materials, process, and cleaning.
• Perform validation impact assessments for change orders and support equipment and facilities change controls.
• Generate and maintain process FMEAs for production processes and conduct risk assessments for non‑conformances and planned deviations.
• Provide content and support for regulatory submissions and notifications.
• Lead cross‑functional teams in validation, risk management, design transfer, and specification development.
• Review change control requests and change orders for quality and validation coverage.
• Propose improvement projects, create supporting data and flowcharts, and lead department and cross‑department initiatives.
• Assist in developing and updating departmental procedures and other controlled documents.
• Evaluate the adequacy of specifications for new or modified process designs.
• Participate in process design reviews, material review board (MRB), and production response team (PRT) meetings.
• Contribute to department process improvement goals and maintain departmental metrics.
• Provide status updates and escalations to management; ramp up independently within 3‑6 weeks of training.
• Support new product introduction (NPI) and sustaining projects, including attending project meetings, drafting validation protocols, and assisting with execution.

• Bachelor’s degree in Science or Engineering.
• Minimum 3 years of experience in validation of custom equipment, analytical methods, process, cleaning, facilities/utilities, or raw materials.
• Authoring experience for validation protocols, master plans, and reports.
• Proficient with change control processes, electronic document management systems, and compliance with 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11.
• Experience with risk analysis, PFMEA, NCE, and PDV assessments.
• Strong knowledge of statistics, SPC, and acceptance sampling.
• Proficient with MS Word, Excel, and Project.
• Excellent attention to detail, problem‑solving skills, and ability to work independently in a fast‑paced environment.
• Effective communication skills and ability to collaborate with cross‑functional teams.

Employees will spend time sitting, standing, walking, and reaching. The role may require lifting or carrying items up to 40 pounds, and exposure to mechanical vibration, moderate noise levels, hazardous chemicals, and blood.

Reported to Brenda Koka. Works closely with cross‑functional quality and operations/manufacturing teams. Team size is 8‑10 members.