Quality Assurance Analyst I

Biolinq Incorporated • San Diego, CA

99d • $75,000 - $78,000

About The Position

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. 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 the supplier management process, including supplier selection, qualification, management and auditing activities. This Analyst will work with cross-functional teams of engineers in R&D, Supply Chain, material inspection, manufacturing, and quality to identify new suppliers and ensure they meet qualification requirements. They will monitor supplier performance, identify performance trends, and assign SCARs if required. Supplier audits may be performed on-site and/or remote to ensure supplier adherence to standards and contractual requirements. This Analyst will update the Approved Supplier List (ASL) and ensure supplier files are kept up to date. This role requires significant attention to detail, great communication skills, and the ability and critical thinking skills to prioritize competing activities. They will also cross train to document control activities such as assigning DHR numbers, organizing and filing records, logbook control, change order management and assignment of training.

Requirements

• Associate degree and 2 years of experience or bachelor’s degree or a combination of education and experience
• Biological, Chemistry, Quality or Engineering discipline preferred
• Minimum of 2 years experience in a Quality related role preferred
• Minimum of 2 years experience in a medical device, biotech or pharmaceutical setting; FDA and or ISO regulated industry, MDSAP or MDR experience a plus
• Experience with electronic quality management systems as well as paper based systems
• Supplier management experience preferred
• 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

• Work with cross-functional teams to identify new suppliers
• Engage with potential suppliers to assess qualification data and certificates for compliance
• Qualify new suppliers based on level of material or services provided to Biolinq
• Oversee active supplier files (current certifications, audit reports, scorecards, etc.) to ensure regulatory and internal compliance
• Manage and update the Approved Supplier List based on audit results, performance metrics, and business needs
• Determine which suppliers require auditing based on performance and requirements and develop the annual supplier audit schedule
• Perform Supplier audits; schedule audits, develop audit agendas, and evaluate suppliers’ QMS based on ISO standards and internal procedures to determine if there are nonconformances. Write audit reports and recommend supplier status
• Develop and analyze supplier scorecards
• Process change controls and assign training lessons in an electronic quality management system
• Communicate effectively with multiple teams to prioritize change orders
• Assign and collect Logbooks and file paper records associated with manufacturing and Quality
• Assign manufacturing device history record numbers
• Assist the Quality team in hosting external audits
• Other tasks as assigned

Benefits

• Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance
• 401(k) plan
• Holidays
• PTO

What This Job Offers

• Education Level: Associate degree
• Number of Employees: 51-100 employees