Sr QC Specialist

Description

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.

The Senior Quality Control (QC) Specialist supports Biolinq’s quality objectives by reviewing production records, ensuring documentation accuracy, and maintaining compliance with regulatory and internal standards. This role helps drive continuous improvement, supports audit readiness, and collaborates with cross-functional teams to uphold product quality throughout the production process.

Conduct thorough reviews of Device History Records (DHRs) to verify compliance with SOPs, work instructions, and regulatory requirements (ISO 13485, 21 CFR Part 820, etc.).

• Perform quality control inspections on products, including in-line checks, label verification, and final goods assessment.
• Lead regular production line audits, proactively identifying compliance risks and escalating issues as appropriate.
• Collaborate with Manufacturing and Quality teams to resolve discrepancies, implement corrective actions, and drive continuous improvement.
• Support audit preparation activities, including documentation review, gap analysis, and readiness assessments for production areas
• Document and report quality metrics related to DHR review and audit readiness.
• Ensure ongoing compliance with evolving regulatory and quality system requirements
• Performs additional duties as assigned.

• High school diploma or GED required. Bachelor’s degree preferred
• 5-7+ years experience in a regulated medical device production environment
• Demonstrated expertise in DHR review, regulatory compliance, and audit preparation.
• Familiarity with Quality Management Systems, Enterprise Resource Planning systems, and equipment management tools (e.g., Master Control, Net Suite/Oracle ERP, BMRAM).
• Ability to work collaboratively across departments
• Strong analytical skills, attention to detail, and problem-solving abilities.
• Excellent verbal and written communication skills.

Work is primarily performed in a production (Clean Room) and office environment.

• 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.

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…