Staff QA Engineer

Description

The company makes continuous glucose monitoring (CGM) systems and is publicly listed on NASDAQ. It started small about 25 years ago and now extends beyond diabetes into consumer health technology and personalized insights, while still developing solutions for serious conditions.

The quality engineering team works across sites and functions to shape the company's products and the processes behind them, helping bring new CGM technology to patients.

The work involves shifting priorities, unclear technical questions, and complex decisions across functions, so a positive, team-minded approach matters.

Responsibilities

• Lead complex, high-risk quality investigations, including root cause analysis, CAPAs, NCMRs and MRB reviews, Health Hazard Evaluations (HHEs), and other product and process risk assessments, then decide disposition and set lasting corrective actions.
• Give technical leadership on risk management, Six Sigma, process capability, statistical analysis, sampling strategy, and risk-based problem solving.
• Find systemic weaknesses in the Quality Management System and lead lasting improvements to procedures, process controls, validation frameworks, FMEAs, and other quality processes across functions and sites.
• Define and lead risk-based validation and qualification strategies, covering equipment and process qualification, Test Method Validation (TMV), measurement system analysis, and software V&V, to keep products compliant and safe across their lifecycle.
• Act as technical lead on large cross-functional initiatives, explaining technical and compliance issues in writing, speaking, and presentations to engineers and senior leaders, and driving agreement across functions and sites.
• Provide risk-based quality guidance for design transfer, commercialization, and major product or process changes, setting firm controls as products and processes scale to high-volume manufacturing.
• Represent Quality in internal audits and external regulatory inspections, offering subject matter expertise, leading responses to complex technical findings, and helping shape quality and compliance strategy.

Requirements

• A Chemical Engineering degree or a similar degree from an accredited college or university, plus substantial quality engineering experience in regulated manufacturing.
• Strong use of quality engineering principles, including risk management, root cause analysis, statistical analysis, process capability, sampling plans, measurement system analysis, and data-driven decisions using tools such as JMP and Excel.
• Proven experience building and assessing risk-based validation strategies, including IQ/OQ/PQ/PV, Test Method Validation (TMV), measurement system analysis and Gage R&R, and software V&V.
• Experience applying risk-based quality engineering to design transfer, commercialization, manufacturing issues, and process changes, moving easily between hands-on problem solving and broader quality strategy.
• Advanced written, oral, and presentation skills to simplify complex technical material, explain risk and recommendations, influence people without direct authority, and present to technical teams, cross-functional partners, and senior leadership.
• A record of working independently with little direction, handling ambiguity, setting technical direction, and leading several high-priority quality initiatives across functions or sites.

Conditions

Travel: 0-5%.

Typically a Bachelor's degree in a technical field and 8-12 years of related experience, or a Master's degree and 5-7 years of equivalent industry experience, or a PhD and 2-4 years of experience.

Pay range: $111,100.00 - $185,100.00.

Location is listed as the US.

AI-supported tools may help with hiring steps, but people make all hiring decisions.

Benefits

• A full, comprehensive benefits package.
• Access to an internal employee community focused on CGM technology.
• Career development through in-house learning programs and/or qualified tuition reimbursement.
• Growth opportunities on a global scale.