Senior Quality Control Specialist
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
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.
Duties and Responsibilities
- 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.
Requirements
- Bachelor's degree in a related field and 3-5 years of relevant experience; OR high school diploma/GED and 7-10 years of relevant experience in a regulated medical device manufacturing environment.
- Demonstrated expertise in DHR review, regulatory compliance, quality system requirements, and audit preparation.
- Familiarity with Quality Management Systems, Enterprise Resource Planning systems, and equipment management tools (e.g., MasterControl, NetSuite/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.
Working Conditions
Work is primarily performed in a production (Clean Room) and office environment.
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.
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.
Pay
The U.S. base salary range reasonably expected to be paid for this role is: $90,000 to $110,000 per year. 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.