Quality Engineer II

Bionano • San Diego, CA

1d • Onsite

About The Position

We are seeking a hands-on Quality Engineer (Level II) to play a critical role in product quality and compliance across both instruments and consumables. This role requires a self-starter who can operate independently, think critically, and uphold high-quality standards. You will be deeply involved in product release, quality systems, and continuous improvement initiatives while partnering closely with engineering, manufacturing, and supply chain.

Requirements

• Self-motivated individual who can work in a multidisciplinary team
• Strong troubleshooting, communication, teamwork skills
• Excellent at multitasking and prioritization of tasks
• Strong interpersonal skills to lead and collaborate with other cross functional partners
• Strong technical writing ability
• Knowledge of ISO 9001,ISO 13485,QSR (21 CFR Part 820), GLP, GCP, and GMP
• Bachelor’s degree in Science, Engineering, or other relevant field required.
• At least3years of experiencerequiredworking in a GMP regulated environment with a good understanding of ISO 9001,ISO 13485, IVD/IVDR/MDR regulations, and 21 CFR Part 820 requirements

Nice To Haves

• Experience with complex life science systems and assays, including automated sample prep systems
• Experience workingwith engineers, chemists,techniciansand analysts to ensure smooth laboratory and plant operations
• Product release,CAPA, Deviation and Non-conformance reporting, internal auditing, complaints, and supplier management experience
• Able to lead investigations and root cause analyses
• Proficiencyin MS Office software applications and statistical analysis
• Lead Auditor and Lead Six Sigma certification preferred

Responsibilities

• Review and verify product release documentation, including Device History Records (DHRs), manufacturing batch records, Certificates of Analysis (COAs), and other quality system records, to ensure accuracy, completeness, and compliance with specifications and procedures (20%).
• Manage CAPA and non conformance program effectively by partnering with internal technical teams to investigate, identify root causes and implement effective corrective actions (20%).
• Manage equipment calibration and preventive maintenance program, ensuring all equipment remains compliant, and support validation activities (IQ, OQ, PQ, PV) (20%).
• Support design control and risk management activities using standard Quality Improvement tools, prepare fishbone diagrams, perform root-cause analysis and provide recommendations to management (20%).
• Support critical supplier quality oversight and performance monitoring. Collaborate with contract manufacturers to ensure product quality and adherence to specifications and build records (10%).
• Other duties as assigned (10%).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level