Senior Quality Assurance & Compliance Specialist

Biolinq Incorporated; San Diego (CA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

Biolinq Incorporated in San Diego, CA, is hiring a Senior Quality Control Specialist to uphold regulatory compliance and drive continuous improvement in a fast-paced manufacturing setting.

You will review DHRs, perform in-line inspections, and lead audits to ensure product quality from development through production. Strong regulatory knowledge and cross-functional collaboration are essential.

Qualifications

• Bachelor’s degree or equivalent experience in a regulated medical device environment.
• 3–5 years of relevant experience in quality control and regulatory compliance.
• Familiarity with quality management systems and ERP tools.

Responsibilities

• Review Device History Records to verify SOP and regulatory compliance.
• Perform in-line, label, and final goods quality inspections.
• Lead regular production line audits and identify compliance risks.
• Collaborate with Manufacturing and Quality teams to fix discrepancies.
• Assist with audit preparation, reviews, and gap analyses.
• Report quality metrics related to DHR review and readiness.

Skills

Analytical skills

Attention to detail

Problem solving

Verbal & written communication

Cross-functional collaboration

Education

Bachelor's degree in a related field

High school diploma / GED + 7–10 years experience

Tools

MasterControl

NetSuite/Oracle ERP

BMRAM

Job description

Biolinq Incorporated in San Diego, CA, is hiring a Senior Quality Control Specialist to uphold regulatory compliance and drive continuous improvement in a fast-paced manufacturing setting.

You will review DHRs, perform in-line inspections, and lead audits to ensure product quality from development through production. Strong regulatory knowledge and cross-functional collaboration are essential.