Job Opportunity:
A Senior Quality Assurance Engineer is required for a dynamic and skilled professional to support the start-up of our first European manufacturing site. 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.
Role Description:
1. 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.
2. You will work closely with, Quality Engineers and Supplier Quality Engineers to develop and implement inspection methods, sampling plans and related procedures.
3. You will provide the primary input to the design, development and implementation of fixtures for measuring component parts in Receiving Inspection.
4. 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.
5. You will create and conduct measurement capability assessments (i.e. Gage Repeatability and Reproducibility).
6. You will create test strategies and conduct process/equipment/measurement method qualifications and validations.
7. You will be involved in planning, managing and prioritizing tasks/projects, tracking progress towards the overall goals and provide periodic updates to management.
8. You will evaluate and determine cause for measurement variation and lead tasks associated with measurement variations.
9. 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.
Required Skills and Qualifications:
* Educational Requirements: Typically requires a Bachelor's Degree in a technical discipline, and a minimum of 5-8 years related 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.