Quality Technician I

• 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.

• 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.

• 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.

• 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.

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