Position Summary:Responsible for prioritizing inspections, conducting testing/measurements, and data collection. The Senior Quality Inspector must apply the methods and procedures prescribed in the Quality System. Must be able to generate and maintain data for the control of documentation, effectively report information, and accurately respond to questions from team members. Additional responsibilities include assessing and communicating non-conformances, and working with internal parties to drive corrective actions (where necessary). Primary purpose is to ensure all assembled products meet specification during in-process and final inspection. 2nd Shift Schedule, Monday - Friday 1:30pm - 9:30pm in our Bedford, MA Location.
Responsibilities:
• Responsible for inspection of medical device materials/products through use of various inspection instruments such as micrometers, calipers, vision system(s) and other measuring equipment.
• Complete, review and maintain acceptance documentation.
• Provide assistance when analyzing data or developing inspection criteria.
• Observe, monitor, and maintain equipment to ensure conformance to requirements/specifications. Coordinate calibration activities as required.
• Generate non-conformance material reports (NMRs) in quality database when necessary.
• May participate in Material Review Board (MRB) Meetings to support discussion of non-conforming materials and disposition, as requested.
• Record and evaluate quality test data.
• Inspect incoming raw materials, parts and assemblies (as required).
• Read and interpret engineering diagrams and blueprints.
• Contribute towards continuous improvement activities.
Requirements:
• 8+ years QC inspection experience, with an emphasis on in-process inspection within the medical device or life sciences industry.
• High School Diploma or GED equivalent, required.
• Experience with high quality precision disposable parts, basic mechanical measurements and methods.
• Ability to execute job function with little to no assistance. Must be capable of taking instruction from 1st shift and executing it on 2nd shift, independently, reporting back as requested.
• Ability to understand work instructions and interpret assembly drawings.
• Working knowledge of Geometric Dimensioning and Tolerancing Methods (GD&T).
• Ability to learn, understand, and perform inspection and testing of optical components, electromechanical assemblies, and other devices through the use of company test procedures and test set-ups, recording inspection and test results as required.
• Familiarity with equipment control methods, such as calibration, maintenance, and qualification.
• Ability to read, interpret, and apply sampling and sampling plans.
• Prior experience with statistical analysis, such as SPC, comparative testing, reliability methods is a plus.
• Ability to work effectively in a team environment, and communicate with various levels throughout the organization.
• Knowledge of cGMP and ISO 13485.
• Working knowledge of MS Word, Excel and Outlook.
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