Senior Quality Engineer

Biolinq Incorporated•San Diego, CA

1h•$85,000 - $110,000

About The Position

The Senior Quality Engineer is responsible for leading Quality Engineering activities with a strong emphasis on design controls, product risk management, and integration of clinical and field feedback into design and quality decisions. This is a hands-on role requiring independent judgment, technical depth, and the ability to influence cross-functional teams to ensure product safety, performance, and regulatory compliance. 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.

Requirements

BS Degree or higher in Mechanical, Electrical, Chemical, Biomedical Engineering or related technical discipline
5+ years experience in a regulated medical device development environment (i.e. 510(k), PMA)
Demonstrated working knowledge of medical device quality systems and regulations, including design controls (21 CFR 820.30), ISO 13485, and associated practices such as Risk Management (ISO 14971) and Design History Files (DHF).
Proven ability to apply statistical and data-driven methods to support design verification, validation, and quality decision-making, including understanding of sample size rationale, variability, confidence, and acceptance criteria.
Experience using statistical and analytical tools (e.g., Excel, JMP, Minitab, R)
Highly proficient with Windows-based business applications, including effective use of Excel for data analysis and Word/PowerPoint for preparation of technical and quality documentation.
Strong organizational and communication skills, with the ability to manage multiple priorities, exercise sound judgment, and clearly communicate complex concepts.
Highly methodical, detail-oriented, and comfortable operating in a fast-paced, evolving development environment.

Responsibilities

Partner closely with R&D and engineering teams to ensure design control activities are properly executed and documented, including development and review of design inputs, outputs, verification and validation strategies, and design changes.
Support development of specifications, test methods, and acceptance criteria to verify and validate design choices using appropriate statistical methods.
Lead and support product risk management activities, including hazard analyses, DFMEA, PFMEA, and linkage of risk controls to design and process requirements.
Lead Quality evaluation of clinical device observations and product complaints, including determination of investigation requirements, assessment of risk and design impact, and ensuring appropriate escalation (e.g. risk file updates, design changes, CAPAs).
Support manufacturing quality activities, including review of Build Requests, risk-based review of Device History Records (DHRs), and execution of manufacturing line audits to verify compliance with approved procedures and specifications.
Support supplier quality activities, including supplier evaluation, qualification, and monitoring, review of supplier nonconformances and investigations, and participating in supplier audits, as needed.
Support maintenance and continuous improvement of the Quality Management System (QMS), including updating SOPs and presenting key Quality metrics as part of Management review.
Support internal and external audits, serving as a key Quality representative during regulatory inspections and notified body audits.