Quality Specialist II

Bionano•San Diego, CA

1d•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 Quality Assurance activities such as batch record review, incoming inspection, and document control to ensure product quality and compliance with established specifications. It also supports identifying quality system gaps, resolving documentation discrepancies, and continuously improving quality processes. Success requires strong attention to detail, cross-functional collaboration, and the ability to support continuous improvement in a growing organization. The position is onsite in San Diego, California, with less than 5% travel expected. The work includes prolonged sitting and standing, repetitive hand and finger movements, handling and reaching, moving through office and other environments (including confined spaces), close visual review of work, and communication with others. It may occasionally involve moving objects up to 30 pounds and working in environments with temperature extremes, hazardous conditions, low ventilation, noise, or small enclosed spaces. Standard computer, telephone, and related equipment are used for communication and recordkeeping. Reasonable accommodations may be made for qualified individuals with disabilities unless doing so would impose an undue hardship.

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.
Strong organizational skills and attention to detail, including the ability to identify documentation discrepancies and follow established procedures.
Ability to multitask and adapt to changing priorities.
Strong interpersonal, verbal, and communication skills, including the 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.
At least 3 years of experience working in a GMP-regulated environment.
Bachelor's degree in Biology, Chemistry, Biomedical Engineering, or a related scientific or technical discipline, or equivalent relevant education and experience may be considered.

Nice To Haves

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.
Experience supporting quality activities for complex life science platforms, diagnostic systems, or assay-based products.

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, required reviews and approvals, and implementation in accordance with 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.
Coordinate required employee training assignments, maintain training records, and assist with training documentation during onboarding.
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.