Senior Quality Control Specialist

Biolinqorporated • San Diego, CA

2d • Hybrid

About The Position

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.

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.

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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior