Quality Specialist II

Bionano • San Diego, CA

5d • Onsite

About The Position

The Quality Specialist supports the implementation and maintenance of Bionano’s Quality Management System (QMS) in accordance with ISO 13485 and applicable customer and regulatory requirements. The role performs key Quality Assurance activities, including batch record review, incoming inspection, and document control, to ensure product quality and compliance with established specifications. It also supports the identification of quality system gaps, resolution of documentation discrepancies, and continuous improvement of quality processes. Success requires strong attention to detail, effective cross-functional collaboration, and the ability to support continuous improvement within a growing organization.

The position is onsite in San Diego, California, with less than 5% travel expected. The work involves prolonged sitting and standing, repetitive hand and finger motions, use of hands and arms, movement around office or other environments, close visual work, communication with others, and occasional movement of objects weighing up to 30 pounds. The work environment may include low or high temperatures, hazardous conditions, low ventilation, noise, and small or enclosed spaces, as well as indoor and outdoor interactions. Standard computer, telephone, and related equipment are used for communication and recordkeeping.

Requirements

• Demonstrated experience in document control, change control, manufacturing batch records, material specifications, and quality record management.
• Working knowledge of ISO 13485 quality management system requirements, Good Documentation Practices (GDP), and IVD/IVDR regulations.
• At least 3 years of experience working in a GMP-regulated environment.
• Strong organizational skills and attention to detail, with the ability to identify documentation discrepancies and follow established procedures.
• Ability to multitask and adapt to changing priorities.
• Strong interpersonal, verbal, and communication skills.
• Ability to negotiate assigned tasks with other departments.
• Ability to coordinate cross-functional quality activities, communicate identified discrepancies, and escalate unresolved quality issues through established channels.
• Proficiency in MS Office software applications.
• Ability to meet the stated physical and work environment requirements, with reasonable accommodations where applicable.

Nice To Haves

• A bachelor's degree in Biology, Chemistry, Biomedical Engineering, or a related scientific or technical discipline is preferred; equivalent relevant education and experience may be considered.
• Experience in Quality Assurance, Quality Systems, Document Control, or a related function within a biotech, diagnostics, medical device, or regulated manufacturing environment is preferred.
• Experience supporting quality activities for complex life science platforms, diagnostic systems, or assay-based products is preferred.

Responsibilities

• Own document and change control activities, including document creation, revision, routing, review, approval, and release.
• Facilitate change control review meetings as needed and coordinate change assessments, reviews, approvals, and implementation in accordance with established procedures.
• Review and approve receiving material specifications and manufacturing batch records for accuracy, completeness, and compliance with quality system requirements.
• Maintain quality and manufacturing records, including their organization, storage, retrieval, and retention in accordance with applicable procedures and recordkeeping requirements.
• Identify documentation gaps and discrepancies and coordinate timely resolution with appropriate departments.
• Assign, track, and maintain controlled identification numbers for quality system documents, records, and other applicable materials.
• Support employee onboarding by coordinating required training assignments, maintaining training records, and assisting with training documentation.
• Prepare and issue Certificates of Analysis in accordance with approved specifications, procedures, and applicable quality requirements.
• Support identification of quality system gaps and process improvement opportunities, coordinating with relevant departments to address issues.
• Perform additional duties as assigned to support Quality operations and organizational objectives.

What This Job Offers

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