Staff QA Engineer

Description

The company is a global leader in continuous glucose monitoring (CGM). It started as a small business about 25 years ago and has since pioneered its industry. It now extends its work beyond diabetes, building personalized, actionable insights for a wider range of health challenges, with the goal of becoming a leading consumer health technology company while still developing solutions for serious conditions.

The quality engineering team works across sites and functions to set direction for both the company's future and its customers' health. The team helps define, support, and improve the processes that bring new CGM technology to patients.

The role is a staff-level position on a team that is at the core of the company's products.

Responsibilities

• Act as technical lead on new high-volume manufacturing automation equipment development teams.
• Interpret regulatory requirements and guide how they are applied, shape equipment and process design requirements, and influence risk-based design decisions.
• Design the validation strategy across programs.
• Own design control, with a focus on design transfer strategy for new products, so that high-volume manufacturing is ready at every global site.
• Work with Operations to move automation from pilot builds to commercial deployment.
• Lead manufacturing quality engineering for the development, process validation, and commercialization of new processes.
• Lead complex investigations, guide material review board (MRB) decisions, and drive systemic improvements to equipment and process designs.
• Align multi-level, cross-functional, and international teams on complex technical and compliance topics, set direction, and settle open questions so implementation is consistent across sites.
• Give expert guidance on governing and strengthening the quality management system, including FMEA methods, process validation architecture, CAPA strategy, process controls, and nonconformance management.
• Find systemic compliance or procedural gaps across programs and sites, then lead teams in building corrective and preventive actions with cross-functional support.
• Represent the organization in internal audits and external regulatory inspections, providing subject-matter expertise and shaping quality strategy and responses.
• Mentor engineers and cross-functional partners to raise quality engineering skill and keep best practices consistent across teams.

Requirements

• Deep hands-on experience with FDA 21 CFR 820, ISO 13485, and related quality management system requirements, with the ability to apply them at system and program level.
• Skill in reviewing and interpreting complex technical documentation, engineering drawings, and specifications, and in helping others do the same.
• Advanced skill in root cause analysis, Six Sigma, structured problem solving, test method validation, software validation, process validation, process capability (such as Cpk/Ppk), lean manufacturing, sampling plans, and statistical analysis.
• Strong proficiency in data analysis tools such as Excel and JMP, and the ability to guide teams toward data-driven decisions.
• Clear, influential communication with people at every level, including engineering, operations, leadership, and global partners.
• Ability to build and drive complete cross-functional quality solutions and get agreement from stakeholders across sites.
• Ability to organize, prioritize, and lead strategic initiatives on your own while contributing as a key member of cross-functional teams.
• Show initiative, ownership, and integrity when driving high-impact quality and compliance improvements.
• Comfortable in a fast-changing environment and willing to support the wider quality and operations organizations as needed.
• Typically a bachelor's degree in a technical discipline 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.

Conditions

Travel of 5-15%.

Compensation range of $111,100.00 - $185,100.00.

US-based role.

The company may use AI-supported tools in hiring, but all hiring decisions are made by people.

Benefits

• Close view of life-changing CGM technology, plus access to the company's employee community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Career development through in-house learning programs and/or qualified tuition reimbursement.