Quality Assurance Analyst I at Biolinq Incorporated

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Dec, 25

Salary

78000.0

Posted On

24 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Supplier Management, Auditing, Critical Thinking, Communication, Regulatory Compliance, ISO Standards, Change Control, Data Analysis, Team Collaboration, Document Control, Manufacturing, Biotechnology, Medical Devices, Quality Management Systems, Performance Metrics

Industry

Medical Device

Description

Description 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 the supplier management process, including supplier selection, qualification, management and auditing activities. This Analyst will work with cross-functional teams of engineers in R&D, Supply Chain, material inspection, manufacturing, and quality to identify new suppliers and ensure they meet qualification requirements. They will monitor supplier performance, identify performance trends, and assign SCARs if required. Supplier audits may be performed on-site and/or remote to ensure supplier adherence to standards and contractual requirements. This Analyst will update the Approved Supplier List (ASL) and ensure supplier files are kept up to date. This role requires significant attention to detail, great communication skills, and the ability and critical thinking skills to prioritize competing activities. They will also cross train to document control activities such as assigning DHR numbers, organizing and filing records, logbook control, change order management and assignment of training. Duties and Responsibilities Work with cross-functional teams to identify new suppliers Engage with potential suppliers to assess qualification data and certificates for compliance Qualify new suppliers based on level of material or services provided to Biolinq Oversee active supplier files (current certifications, audit reports, scorecards, etc.) to ensure regulatory and internal compliance Manage and update the Approved Supplier List based on audit results, performance metrics, and business needs Determine which suppliers require auditing based on performance and requirements and develop the annual supplier audit schedule Perform Supplier audits; schedule audits, develop audit agendas, and evaluate suppliers’ QMS based on ISO standards and internal procedures to determine if there are nonconformances. Write audit reports and recommend supplier status Develop and analyze supplier scorecards Process change controls and assign training lessons in an electronic quality management system Communicate effectively with multiple teams to prioritize change orders Assign and collect Logbooks and file paper records associated with manufacturing and Quality Assign manufacturing device history record numbers Assist the Quality team in hosting external audits Other tasks as assigned Requirements Qualifications Associate degree and 2 years of experience or bachelor’s degree or a combination of education and experience Biological, Chemistry, Quality or Engineering discipline preferred Minimum of 2 years experience in a Quality related role preferred Minimum of 2 years experience in a medical device, biotech or pharmaceutical setting; FDA and or ISO regulated industry, MDSAP or MDR experience a plus Experience with electronic quality management systems as well as paper based systems Supplier management experience preferred 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 Work on-site in an open office environment 15% travel Physical Requirements While performing the duties of this job, the employee is regularly required to work on a computer, stand; walk; sit; use hands to 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 used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace. As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $75,000-$78,000 annually. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process. Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at Careers@biolinq.com

Responsibilities

The Quality Assurance Analyst I will focus on the supplier management process, including supplier selection, qualification, management, and auditing activities. This role requires collaboration with cross-functional teams to ensure suppliers meet qualification requirements and adhere to standards.