QA & Documentation Specialist II

Biolinq, Inc.; Northern, San Diego (KY, CA); Hybrid; USD 80,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

Biolinq, Inc. is seeking a Quality Assurance Analyst II to join the Quality team. You will process change orders, create training materials, and manage document control within an FDA/ISO-regulated medical device environment.

Responsibilities include organizing records, coordinating with cross‑functional groups, conducting trainings, and supporting supplier management and audits. A strong attention to detail is essential.

Qualifications

• Associate degree and 4 years of experience; Bachelor’s degree preferred.
• Minimum of 3 years’ experience in Quality Document Control.
• Experience in a medical device, biotech or pharmaceutical setting, FDA/ISO regulated industry required; MDSAP or MDR experience preferred.

Responsibilities

• Process Change Orders in an electronic quality management system, ensuring compliance and coordinating revisions.
• Create and assign training lessons in the electronic QMS and attach necessary documents.
• Organize, collect and file paper records related to manufacturing and Quality.
• Communicate with multiple teams to prioritize change orders.
• Assign device history records and document numbers; manage logbooks.

Education

Associate degree with 4 years experience

Bachelor’s degree preferred

Tools

MasterControl

Job description

Biolinq, Inc. is seeking a Quality Assurance Analyst II to join the Quality team. You will process change orders, create training materials, and manage document control within an FDA/ISO-regulated medical device environment.

Responsibilities include organizing records, coordinating with cross‑functional groups, conducting trainings, and supporting supplier management and audits. A strong attention to detail is essential.