Senior Quality Assurance Specialist

The Company is a global leader in continuous glucose monitoring (CGM). We began with a big dream: To forever change how diabetes is managed. Our vision has expanded beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges.

We are driven by ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more.

Our Quality Assurance team is looking for a dynamic and skilled Quality Assurance Engineer to support the start-up of our first European manufacturing site in Athenry. As a member of the Receiving Inspection team, this engineer will liaise closely with R&D, Supplier Quality and Operations Engineering to ensure open and timely communication of pipeline project deliverables including but not limited to, material specifications, drawings, requirements, fixture design and development, Gage Repeatability & Reproducibility Studies, First Article Inspections, inspection procedures, inspection methods and sampling plans.

You will also support the Supervision and Training of laboratory personnel. Your primary responsibilities will include evaluating inspection methods, process improvements, sampling plans, coordination of first article component and fixture inspections, selection and qualification of inspection equipment. You will work closely with Quality Engineers and Supplier Quality Engineers to develop and implement inspection methods, sampling plans and related procedures.

You will provide the primary input to the design, development and implementation of fixtures for measuring component parts in Receiving Inspection. Additionally, you will develop inspection processes for complex and high-volume component throughput and design and develop methods to determine measurement accuracy and precision through testing and analysis.

You will create and conduct measurement capability assessments (i.e. Gage Repeatability and Reproducibility). You will create test strategies and conduct process/equipment/measurement method qualifications and validations. You will be involved in planning, managing and prioritizing tasks/projects, tracking progress towards the overall goals and provide periodic updates to management.

You will evaluate and determine cause for measurement variation and lead tasks associated with measurement variations. You will be responsible for OOS events, CAPAs, NCMRs and Change Order; establishing and maintaining communication to key stakeholders, reporting, investigation, disposition and the corrective action process.

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
• Proficiency with engineering software tools for CAD (SolidWorks preferred), engineering analysis, and statistical analysis (e.g. Minitab) and Microsoft Office Products is desirable.
• You will be proficient with basic statistical analysis (normality, standard deviation, variance, and comparison of data groups) including Gage R&R and test method validations.
• You will be proficient with geometric dimensioning and tolerancing and can read mechanical drawings.
• You will be proficient in inspection equipment and fixture design, development and implementation.

• A front row seat to life changing CGM technology.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

• Travel Required: 0-5%