Quality Technician I

Title: Quality Technician IReports to: Quality ManagerSummary: Primary duties of this position will be to work from engineering drawings, work instructions and other established specifications to determine acceptance, rejection of product within company directives and operating procedures consistent with FDA, GMP, ISO 9001 and ISO 13485 guidelines. The Quality Technician I will have experience in the setup, adjustment, alignment as well as a demonstrated ability to safely run basic to moderately complex inspection equipment. The Quality Technician I will perform visual and dimensional inspections using visual standards and inspection tools including programmable coordinate measuring machines (CMM). They will use procedures including sampling plans to conduct component and assembly inspections. The Quality Technician I will also collect and analyze data using software programs. Additional responsibility will include the tracking of items within the calibration system and coordinating outside calibration of measuring and test instrumentation and or conducting internal documentation audits.Duties/Responsibilities include but are not limited to:Maintains a clean work area and utilizes safe working practices.Triaging nonconformance's creating and processing MRB/DMR's as appropriate. Performs inspections as required.Performs first piece and product inspections as necessary for Value Streams.Provides traceable verification by completing inspection documentation or other documents for all components, assemblies, and/or product lots inspected, as required by inspection documentation.Performs evaluation of returned goods to verify integrity as requested by the Material Review Board (MRB).Maintains control of items in the inspection process.Provides training and feedback to associates in quality practices, acceptance criteria and measurement technique. Identifies process/product discrepancies and communicates them through the non-conformance procedure.Prepares necessary reports including documenting test results and statistics.Maintains electronic inspection data using established procedures and file naming conventions.Retains records according to company policy and samples from inspections.Participates in team meetings as required.Wears personal protective equipment as required.Ensures all activities are in compliance with Quality System requirements.Acts as a quality resource for Value Streams.Accountabilities: Positively contributes to achieve company's safety goals.Accountable for company quality and service goals.Accountable for processing assigned inspections assuring they are complete and accurate with no attributable findings within allotted time frame.Accountable for Work Habit Verification for accurate electronic/physical data.Accountable for coordinating outside calibration of measuring and test instrumentation and or conducting internal documentation audits. Accountable for maintaining current learning and development as required for position.Training/Education/Experience:High School diploma minimum.Post-secondary education in a technical program preferred. 3-5 years of related experience in a manufacturing environment; medical device industry experience a plus.Trained to read and interpret basic to moderately complex engineering drawings and specifications.Trained and practice in the use of basic to moderately complex dimensional and nondestructive inspection tools ranging from calipers to the operation of coordinate measuring machines.Proficient using Microsoft office.Experience using an enterprise resource planning (ERP) software system helpful. Trained in FDA GMP and/or ISO 9001 and ISO 13485 guidelines.ASQ Quality Technician certification a plus.Competencies/Talents/Personal Attributes:Excellent communication and writing skills.Exhibits a professional demeanor at all times.Ability to read and understand verbal and written instructions.Identify process/product non-conformances or borderline quality conditions that may require corrective action.Working knowledge of inspection sampling plans (i.e., ANSI C=0).Excellent hand/eye coordination, manual dexterity, and vision.Detail oriented.Strong desire for continuous learning. Can speak, understand and write English.