Quality Inspection Failure Analysis 3 - Swing Shift

Intuitive•Peachtree Corners, GA

5d•Onsite

About The Position

This role is responsible for performing failure analysis on defective medical instruments and accessories. The primary function involves independently following instructions to inspect and test complex medical instrumentation, documenting findings in the Quality Management System. The position also entails timely processing and dispositioning of returned instruments, accessories, and RMAs. Regular use of diagnostic software and specialized testing equipment is required to identify and localize equipment and system problems. The role requires effective communication, problem-solving skills, and the ability to mentor new team members. A strong understanding of engineering drawings, schematics, and assembly documentation is necessary. The position also involves recommending and implementing process improvements for the RMA workflow and ensuring compliance with all safety, SOP, and DOP procedures.

Requirements

Minimum high school diploma and AA or equivalent.
Minimum 2 years related experience or training; or equivalent combination of education and experience.
Ability to read, write and understand English.
Ability to read and understand work instructions.
Ability to do basic math.
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.
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.
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.
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 and commonly used chemical compounds such as epoxy, denatured alcohol and acetone.
General knowledge of PPE usage.
Willing and able to work extended hours when necessary.

Nice To Haves

AA or college degree preferred.

Responsibilities

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.
Perform Instrument repacking process, including execution of label printing work orders.
Document 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.