SummaryWe 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.
Primary Duties and 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%).
Required Skills and Abilities- 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
Preferred Skills and Abilities- 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
Education, Certifications, Licenses- 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
- Certifications required/ preferred: Lead Auditor and Lead Six Sigma certification preferred
Leadership Responsibility (Direct/ Indirect): N/A
Additional Requirements - Work Location: Onsite-San Diego
- Travel Requirements:
- Up to 10%of travel time expected
- Physical Requirements and Work Environment:
- Sit and stand for prolonged periods
- Repeating motions that may include the hands,wristsand/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 to 20 pounds 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 record keeping
- Able to travel, including international travel, without personal assistance
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.
