Quality Assurance Analyst II

Role summary

Quality Assurance Analyst II is a role at Biolinq Incorporated in San Diego, California, United States (on-site). Posted 2026-09-10. Salary: USD 80,000–95,000 per year. Experience level: 2-5.

Job title

Quality Assurance Analyst II

Company

Biolinq Incorporated

Location

San Diego, California, United States

Work arrangement

on-site

Category

QA & Testing

Salary

USD 80,000–95,000 per year

Experience level

2-5

Date posted

2026-09-10

Job description

Description

WARNING about fake job posting scams. There has been a recent wave of scams whereby third parties post fake job openings using a bogus email address that resembles xxxx@biolinq.com . Under the guise of asking you to fill out an application, the scammers are attempting to gather your personal information. See the Federal Trade Commission’s warning on this topic at: https://consumer.ftc.gov/articles/job-scams

The only official source for actual Biolinq job postings/openings is at www.biolinq.com/careers . While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit www.biolinq.com/careers to verify the accuracy of the openings found on third party web sites.

About the Company

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.

Job Purpose

This is a key role as part of the Quality team interacting with multiple departments at Biolinq. This highly visible role within the Quality department will focus on processing change orders from cross-functional teams of engineers in chemistry, software, hardware, manufacturing, and quality and setting up the required training associated with the document contained within the change orders. They will be responsible for additional document control activities such as assigning document and DHR numbers, organizing and filing records, and logbook control. They may also contribute to the supplier management program and management of NCMR and CAPA events. This role requires significant attention to detail, great communication skills, and the ability and critical thinking skills to prioritize competing projects.

To be successful as a Quality Assurance Analyst II, you should demonstrate strong attention to detail and have analytical and problem-solving abilities. The ideal candidate must be able to interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues.

Duties and Responsibilities

Process Change Orders in an electronic quality management system, performing review for compliance to work instructions and working with submitters to revise change orders as required.

Create and assign training lessons in an electronic quality management system, ensuring the correct documents are attached to the training lessons, creating course quizzes as applicable, and assigning lessons to the appropriate employees.

Organize, collect and file paper records associated with manufacturing and Quality

Communicate effectively with multiple teams to prioritize change orders

Control the assignment and collection of Logbooks

Assign manufacturing device history record and document numbers

Conduct in-person training sessions for employees on various topics

Conduct employee on-boarding training on Quality related topics

Create and or revise procedures or work instructions in areas of focus

Conduct investigations as assigned for NCMR or CAPA events

Contribute to the Supplier Management process; update ISO certificates, update supplier spreadsheet, etc.

Pull reports for departmental metrics

Assist the Quality team in hosting external and customer audits

Other tasks as assigned

Requirements

Associate degree and 4 years of experience; Bachelor’s degree preferred. Or an equivalent combination of experience and education.

Biological, Chemistry, Quality or Engineering discipline preferred

Minimum of 3 years’ experience in Quality Document Control desired

Minimum of 3 years’ experience in a medical device, biotech or pharmaceutical setting, FDA and or ISO regulated industry required; MDSAP or MDR experience preferred

Experience with electronic quality management systems as well as paper based systems. Experience with MasterControl highly desirable

Critical thinking skills

Ability to interface and communicate with multiple departments and work in a fast-paced, multi-disciplinary environment

Capacity to manage multiple tasks and communicate clearly to the team; excellent written and verbal communication skills

Experience with internal and external audit activities a plus

Working Conditions

General Office and Laboratory.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.

BENEFITS

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be use