Quality & Documentation Analyst II

Biolinq Incorporated; San Diego (CA); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid Time Off

Job summary

Biolinq Incorporated in San Diego seeks a Quality Assurance Analyst II to join the Quality team. You will process change orders, create training modules, and manage documentation and logbooks in a fast-paced, cross-functional setting.

You will also lead investigations for NCMR/CAPA events, support supplier management, and prepare for internal and external audits while maintaining rigorous QA standards and clear communication across departments.

Qualifications

• Associate degree and 4 years of experience; Bachelor’s degree preferred. Or an equivalent combination of experience and education.
• Biological, Chemistry, Quality or Engineering discipline preferred
• Minimum of 3 years’ experience in Quality Document Control
• Minimum of 3 years’ experience in a medical device, biotech or pharmaceutical setting, FDA and or ISO regulated industry required; MDSAP or MDR experience preferred
• Experience with electronic quality management systems as well as paper based systems. Experience with MasterControl highly desirable
• Critical thinking skills
• Ability to interface and communicate with multiple departments and work in a fast‑paced, multi‑disciplinary environment
• Capacity to manage multiple tasks and communicate clearly to the team; excellent written and verbal communication skills
• Experience with internal and external audit activities a plus

Responsibilities

• Process Change Orders in an electronic quality management system, performing review for compliance to work instructions and working with submitters to revise change orders as required.
• Create and assign training lessons in an electronic quality management system, ensuring the correct documents are attached to the training lessons, creating course quizzes as applicable, and assigning lessons to the appropriate employees.
• Organize, collect and file paper records associated with manufacturing and Quality
• Communicate effectively with multiple teams to prioritize change orders
• Control the assignment and collection of Logbooks
• Assign manufacturing device history record and document numbers
• Conduct in‑person training sessions for employees on various topics
• Conduct employee on‑boarding training on Quality related topics
• Create and/or revise procedures or work instructions in areas of focus
• Conduct investigations as assigned for NCMR or CAPA events
• Contribute to the Supplier Management process; update ISO certificates, update supplier spreadsheet, etc.
• Pull reports for departmental metrics
• Assist the Quality team in hosting external and customer audits
• Other tasks as assigned

Skills

Attention to detail

Analytical thinking

Quality assurance

Cross-functional communication

Education

Associate degree

Bachelor’s degree preferred

Tools

MasterControl

QMS software

Job description

Biolinq Incorporated in San Diego seeks a Quality Assurance Analyst II to join the Quality team. You will process change orders, create training modules, and manage documentation and logbooks in a fast-paced, cross-functional setting.

You will also lead investigations for NCMR/CAPA events, support supplier management, and prepare for internal and external audits while maintaining rigorous QA standards and clear communication across departments.