Senior Quality Assurance Inspector

6 days ago

Cork, Cork, Ireland beBeeInspector Full time €120,000 - €140,000

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:

  • 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.

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.

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