Quality Inspection Failure Analysis 3

Job Description

Primary Function of Position

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

Independently follows oral and/or written instructions in performance of a wide variety of inspections and testing of complex medical instrumentation and documents findings in Quality Management System.  Responsible for timely processing and dispositioning of returned instruments and accessories.

Responsible for the timely processing and dispositioning of all RMA’s, with focus on Instruments and accessories.

Regularly use of diagnostic software for localizing equipment and system problems, specialized testing equipment, analyzers, digital oscilloscopes, digital multimeters, clocks, timers, calipers, voltmeters, power supplies, rulers, and other test equipment as required.

Essential Job Duties

• Perform failure analysis of defective instruments and accessories by evaluating the mechanical, electrical, and physical characteristics of returned items.
• Perform Disposition of Excess and System Trade in RMA I&A returns
• Documenting failure analysis findings in clear and concise way in QMS system
• Assist Advance FA team on regulatory requirements in resolving “Reportable I/A” events and “Recalled” instruments.
• Regular communication with failure analysis engineering group and post market surveillance
• Able to perform Failure analysis of Core instrumentation and accessories.
• Able to independently resolve minor to moderate problems.
• Builds important internal/external relationships through advanced communication skills; knows how to influence and negotiate effectively through communications.
• Mentors new team members as needed.
• Ability to verify assembly documentation accuracy, read engineering drawings etc. Sets up and operates machines/equipment /fixtures needed to perform inspection and testing processes.
• Understands diagrams, schematics, assembly drawings, fab drawings, mechanical component drawings.
• Recommend/implements RMA process workflow improvements.
• Disposes bio-hazardous material as required.
• Performs “Purging tasks” for all the completed RMA’s if applicable.
• Maintains knowledge of DOP’s, SOP’s and MPI’s pertaining to I/A RMA operations.
• Works independently towards daily and throughput targets.
• Follows all corporate, safety, SOP, DOP procedures and regulations.
• Maintains a clean and orderly work area.

Qualifications

Qualifications

Required Education, Skills, and Training

• Education and/or Experience: Minimum High school diploma and AA or equivalent Minimum of AA or college degree preferred; 2-4 years related experience or training; or equivalent combination of education and experience.
• Language Skills: Ability to read, write and understand English. Ability to read and understand work instructions. 
• Mathematical Skills: Ability to do basic math.
• Reasoning Ability: Ability to apply logical, sensible understanding to carry out instructions. Ability to deal with situations including up to several variables. Ability to report actual or potential quality issues. Ability to suggest and implement process improvements.
• Computer skills: Proficient in use of personal computers as part of daily work, including knowledge of the Microsoft Office suite and SAP ERP System, ACCS (Agile) system (our quality system) to retrieve and submit on-line documentation.
• Ability to communicate effectively with technical and non-technical internal customers.
• Acute attention to detail; excellent organizational skills.
• High level of professional integrity and ethics
• Ability to work varying shifts.
• Must have ability to complete training courses.
• Ability to work in a team environment.

Working Conditions

• Ability to lift 50lbs.
• Able to use office and test equipment in a typical office/light manufacturing environment.
• Repetitive motion. Substantial continual motion.
• Excellent hand-eye coordination.
• Vision abilities required include close, distance, color, depth and ability to adjust focus.

Work Environment:

• Typical production & repairs environment.
• General knowledge of clean and organized work areas and practices.
• High urgency and stress associated with customer deadlines.
• Some work in controlled environment with handling of unsterilized medical instrumentation
• Some risk of exposure to electrical shock