Summary
Bionano is looking for a proven quality player coach to join Bionano’s senior leadership, reporting directly to the Chief Operating Officer, with responsibility for driving Bionano’s quality assurance and compliance strategies. This person will be hands on in executing the Quality Management System (QMS) that relies on OEM partners for ISO 13485 compliance. This role ensures robust supplier management, document control, CAPA management, and compliance with the EU’s IVDR and other global regulatory requirements.
The ideal candidate will have experience in executing and managing quality for outsourced manufacturing environments and driving continuous improvement across the supply chain. This person will have minimal direct staff and will work through other Bionano organizations, OEM partners and outsourced staff. This is a full-time position located in our San Diego headquarters, with key suppliers and distribution centers located globally.
Primary Duties and Responsibilities
- Establish and oversee Bionano’s quality management system (QMS)
- Responsible for company’s Quality Assurance programs to ensure compliance with regulatory agencies, all applicable standards
- Collaborate cross-functionally with internal departments on strategy and implementation of quality principles and regulation requirements
- Manage the Document Control function
- Maintain technical documentation, DHFs, and risk management files for regulatory submissions
- Support CE-IVDR certification activities, including gap assessments, risk management, and technical documentation updates
- Develop and execute supplier qualification, monitoring, and auditing programs for OEM partners and critical suppliers
- Ensure quality agreements, risk-based evaluations, and compliance with MDR/IVDR supplier control requirements
- Lead CAPA investigations, root cause analysis, and effectiveness checks using structured methodologies (e.g., 5 Whys, Fishbone)
- Ensure timely closure and documentation of CAPA per QMS requirements
- Other duties as assigned.
Required Skills and Abilities
- Proven record of leadership of quality functions supporting devices that include reagents, consumables, software, and complex instruments
- Experience with products registered under IVDD or IVDR in Europe
- Proven experience managing ISO QMS, supplier quality programs, and OEM relationships
- Expertise in document control systems, CAPA processes, and risk management
- Strong communications skills; oral, written, electronic and presentation
- Strong organizational skills
- Must be flexible and adaptable in a fast-paced environment
Preferred Skills and Abilities
- Lean Six Sigma certification or equivalent continuous improvement experience
Education, Certifications, Licenses
- Education (Level and field of study) required/ preferred: Bachelor’s degree in engineering, sciences, or related fields required. Advanced degree preferred.
- Years relevant/ total work experience: 7+ years of experience in quality within the life science industry.
- Certifications required/ preferred: N/A
Leadership Responsibility (Direct/ Indirect): May directly manage at least 1 employee.
Additional Requirements
- Work Location: Onsite – San Diego, CA
- Travel Requirements:
- Minimal travel time expected
- Physical Requirement sand Work Environment:
- Sit and stand for prolonged periods
- Repeating motions that may include the hands, wrists and/or fingers
- Use of hands to finger, handle, or feel, and reach with hands and arms
- Stand and/or move about the office or in various environments (including tight and confined spaces), or from one worksite to another
- Specific visual abilities, including close vision and ability to adjust focus, read, review, and assess the accuracy and thoroughness of the work assigned
- Verbal abilities require communicating with others to exchange information
- Occasionally adjusting or moving objects up to50pounds in all directions
- Work environment involving low/high temperatures; hazardous conditions, low ventilation, noisy environments, small/enclosed spaces
- In-person interaction with others indoors and outdoors
- Use standard computer, telephone and related equipment for communication, and recordkeeping
The above physical requirements and work environment characteristics generally reflect those of this position but is not an exhaustive list. Reasonable accommodations may be made to enable individuals with qualified disabilities to perform the essential functions of the position, provided that such accommodation does not impose an undue hardship on the Company. Disclaimer Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
This description generally reflects management’s assignment of essential functions but is not intended to be a comprehensive list of the duties and responsibilities of the position, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice.
