Quality Assurance Analyst II

Biolinqorporated•San Diego, CA

2d•Onsite

About The Position

This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health. This is a key role as part of the Quality team interacting with multiple departments at Biolinq. This highly visible role within the Quality department will focus on processing change orders from cross-functional teams of engineers in chemistry, software, hardware, manufacturing, and quality and setting up the required training associated with the document contained within the change orders. They will be responsible for additional document control activities such as assigning document and DHR numbers, organizing and filing records, and logbook control. They may also contribute to the supplier management program and management of NCMR and CAPA events. This role requires significant attention to detail, great communication skills, and the ability and critical thinking skills to prioritize competing projects. To be successful as a Quality Assurance Analyst II, you should demonstrate strong attention to detail and have analytical and problem-solving abilities. The ideal candidate must be able to interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues.

Requirements

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 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