Plymouth, MN

Job Description


Our smaller medical device client is adding a Sr. Quality Assurance Technician to the team! The Sr. QA Tech will be performing routine inspection of raw materials and components, as well as, in-process and final inspection of finished devices. This role will design and develop new processes, tests methods, and/or control systems, and ensure that all Quality-related job responsibilities are carried out according to established procedures and policies.

Your role with the company:

·                Follows set training program for position and ensures training requirements are up to date.

·                Interacts with Manufacturing to support product quality issues.

·                Interprets and understands internal drawings and specifications to inspect received (incoming) materials in accordance with purchase orders and specifications.

·                Performs start-up, in-process and final product inspections.

·                Measures dimensions of materials/components/product using precision tools such as calipers, gages, microscopes, comparators, etc.

·                Measures electrical and optical components/assemblies using power meters, multimeters, PCB inspection tools and jigs.

·                Maintains highly accurate and legible quality records and reviews quality records for completeness.

·                Makes recommendations on decisions as to the acceptable quality; reasons for rejection; completes required quality records.  Identify, initiate quarantine, report and document all non-conforming product.

·                Identifies, reports and documents all discrepancies and potential product quality problems.  Participates in root cause analysis.  Assists QE in non-conforming material/part transactions, management and tracking of non-conformances.

·                Develop and execute First Article Inspection reports. Supports Gage R&R, Qualifications and Validations.

·                Develops inspection test methods and drafts Inspection Procedures with QE.

·                Perform peer review of inspection reports to ensure complete and accurate results have been documented.

·                Identify improvement opportunities and implement process changes.

·                Performs general maintenance, calibration, and orders spare parts on assigned test equipment.

·                Demonstrates safe work habits, maintains clean and safe work area.

·                May perform other duties as assigned.


Desired Profile:


·                  A high school diploma or GED required

·                  Minimum five years of inspection experience in Medical Device manufacturing or other regulated industry.

·                  Experience in drafting technical reports, inspection/test methods, and other quality documents.

·                  Experience in interpreting internal drawings and specifications to appropriate inspection methods is highly preferred. Knowledge of design documentation standards (e.g. ASME Y14.5M, Y14.1) is a plus.

·                  Experience inspecting electrical and optical components/assemblies. IPC-A-620/IPC-A-610 certification is a plus.

·                  Experience programming vision, CMM, and other automated test systems.

·                  Knowledge of measurement systems (SI, English), perform measurement conversions (scientific, decimals, and fractions).

·                  Working knowledge of statistical concepts such as statistical process control, control charting (variable, attribute) and capability is a plus. 

·                  Must be proficient in the use of computer software applications, (Microsoft Excel, Word, SPC).  Experience using Agile a plus.

·                  Quality Technician Certification from ASQ is a plus.




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