QA Analyst II: Document Control & Training Lead

Socket.dev; San Diego (CA); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Health Savings Account

Flexible Spending Account

Life insurance

Long-term disability insurance

401(k) plan

Holidays

Paid time off

Job summary

Biolinq is actively seeking a Quality Assurance Analyst II to join the Quality team. The role focuses on processing change orders from cross-functional teams and setting up training materials related to those changes.

You will manage document numbers, logbooks, and records, contribute to supplier management and CAPA/NCMR events, and support internal and external audits. Strong attention to detail and clear communication are essential.

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; MasterControl highly desirable
• Critical thinking skills
• Ability to interface with multiple departments in a fast-paced environment
• Excellent written and verbal communication skills

Responsibilities

• Process Change Orders in an electronic quality management system; revise as required.
• Create and assign training lessons; attach documents and quizzes as applicable.
• Organize, collect and file paper records related to manufacturing and Quality.
• Communicate 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 on Quality topics.
• Conduct employee onboarding training on Quality topics.
• Create or revise procedures or work instructions.
• Conduct investigations for NCMR or CAPA events.
• Contribute to Supplier Management; update ISO certificates and supplier spreadsheets.
• Pull reports for departmental metrics.
• Assist the Quality team in external and customer audits.
• Other tasks as assigned

Skills

Attention to detail

Analytical skills

Problem solving

Communication skills

Education

Associate degree

Bachelor's degree

Equivalent combination of experience and education

Tools

MasterControl

Job description

Biolinq is actively seeking a Quality Assurance Analyst II to join the Quality team. The role focuses on processing change orders from cross-functional teams and setting up training materials related to those changes.

You will manage document numbers, logbooks, and records, contribute to supplier management and CAPA/NCMR events, and support internal and external audits. Strong attention to detail and clear communication are essential.