QA Analyst II – Medical Device Quality & Document Control

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) plan

Job summary

Biolinq is seeking a Quality Assurance Analyst II to join our San Diego team. This role works within the Quality department to process change orders, manage document control, and deliver training materials for cross-functional engineers and staff.

The role requires attention to detail, strong communication, and the ability to prioritize multiple projects while upholding regulatory standards in a fast-paced biotech environment.

Qualifications

• Associate degree and 4 years of experience; Bachelor’s degree preferred.
• Biological, Chemistry, Quality or Engineering discipline preferred
• Minimum of 3 years’ experience in Quality Document Control desired
• 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

Quality Assurance

Document Control

Change Management

Training Delivery

Interdepartmental Communication

Education

Associate degree

Bachelor’s degree preferred

Tools

MasterControl

Job description

Biolinq is seeking a Quality Assurance Analyst II to join our San Diego team. This role works within the Quality department to process change orders, manage document control, and deliver training materials for cross-functional engineers and staff.

The role requires attention to detail, strong communication, and the ability to prioritize multiple projects while upholding regulatory standards in a fast-paced biotech environment.