Senior Quality Assurance Engineer
About the Role:
* You will work directly in the Receiving Inspection Department, 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.
* 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.
Requirements:
* A Bachelors degree in Quality Engineering, Manufacturing Engineering or a related field with a minimum of 5 years relevant industry 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.
* You have the ability to run self-directed projects, maintain timelines, transfer technology and execute projects in an R&D and GMP manufacturing environment.
* You can deal with ambiguity/uncertainty and a willingness to try new/challenging things.
* You can demonstrate strong interpersonal and teamwork skills and written and verbal communication skills.
Benefits:
* 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 organisation committed to our employees, customers, and the communities we serve.
What You'll Get: