Biolinq · 2 months ago
Sr QC Specialist
San Diego,CA,US
Full-time
Onsite
Senior Level
$28/hr - $32/hr
5+ years expBiolinq 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. 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.
BiotechnologyHealth CareMedical DeviceWearables
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
Qualification
Required
High school diploma or GED required
5-7+ years experience in a regulated medical device production environment
Demonstrated expertise in DHR review, regulatory compliance, and audit preparation
Ability to work collaboratively across departments
Strong analytical skills, attention to detail, and problem-solving abilities
Excellent verbal and written communication skills
Preferred
Bachelor's degree preferred
Familiarity with Quality Management Systems, Enterprise Resource Planning systems, and equipment management tools (e.g., MasterControl, NetSuite/Oracle ERP, BMRAM)
Benefits
Medical
Dental
Vision
Health savings account
Flexible spending account
Life and long-term disability insurance
401(k) plan
Holidays
PTO
Company
Biolinq
Biolinq develops a wearable biosensor platform that is capable of measuring blood level information.
51-200 employees
H1B Sponsorship
Biolinq has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$276.3MKey Investors
Alpha Wave VenturesRiverVestM Ventures
2025-03-19Series C· $100M
2024-04-04Series Unknown· $58M
2021-11-02Series B· $100M
Leadership Team
Rich Yang
CEO
Jared Tangney
Co-Founder, President & CTO
Recent News
2025-12-24
Crunchbase News
2025-10-20
Company data provided by crunchbase