Senior Quality Control Specialist – Regulated Medical Devices

Socket.dev; San Diego (CA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan

PTO / holidays

Job summary

Biolinq is seeking a Senior Quality Control Specialist to review production records, ensure documentation accuracy, and maintain regulatory compliance across the manufacturing process.

You will lead DHR reviews, perform in-line inspections, and support audit readiness while collaborating with cross-functional teams to uphold product quality and continuous improvement. Strong analytical skills and clear communication are essential.

Qualifications

• Bachelor's degree in a related field with 3–5 years of relevant experience in a regulated medical device environment.
• Demonstrated expertise in DHR review, regulatory compliance, quality systems, and audit preparation.
• Familiarity with Quality Management Systems, ERP tools, and equipment management software.

Responsibilities

• Review Device History Records (DHRs) for SOP and regulatory compliance.
• Perform quality control inspections and label verification on products.
• Lead production line audits and escalate compliance risks accordingly.
• Collaborate with Manufacturing and Quality teams to drive CAPAs and continuous improvement.
• Support audit readiness and documentation reviews for production areas.
• Report quality metrics related to DHR and audit readiness.

Skills

DHR review

Regulatory compliance

Audit preparation

QMS familiarity

ERP systems

Cross-functional collaboration

Analytical skills

Verbal and written communication

Education

Bachelor's degree in a related field

Tools

MasterControl

NetSuite/Oracle ERP

BMRAM

Job description

Biolinq is seeking a Senior Quality Control Specialist to review production records, ensure documentation accuracy, and maintain regulatory compliance across the manufacturing process.

You will lead DHR reviews, perform in-line inspections, and support audit readiness while collaborating with cross-functional teams to uphold product quality and continuous improvement. Strong analytical skills and clear communication are essential.