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 skills, the ability to mentor new team members, and a strong understanding of engineering drawings and schematics. The position operates in a typical office/light manufacturing environment with potential exposure to bio-hazardous materials and chemicals, and requires the ability to work varying shifts, including swing shift, and potentially extended hours.

Requirements

Minimum high school diploma and AA or equivalent.
Minimum 2 years of 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, including Microsoft Office suite.
Proficient in SAP ERP System and ACCS (Agile) system.
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.
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.
General knowledge of PPE usage.
Willing and able to work extended hours when necessary.

Nice To Haves

AA or college degree preferred.
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.

Responsibilities

Perform failure analysis of defective instruments and accessories by evaluating their mechanical, electrical, and physical characteristics.
Process and disposition Excess and System Trade in RMA I&A returns.
Perform Instrument repacking process, including execution of label printing work orders.
Document failure analysis findings clearly and concisely in the QMS system.
Assist the Advance FA team on regulatory requirements for "Reportable I/A" events and "Recalled" instruments.
Communicate regularly with the failure analysis engineering group and post-market surveillance.
Perform failure analysis of Core instrumentation and accessories.
Independently resolve minor to moderate problems.
Build important internal/external relationships through advanced communication skills, influencing and negotiating effectively.
Mentor new team members as needed.
Verify assembly documentation accuracy and read engineering drawings.
Set up and operate machines/equipment/fixtures needed for inspection and testing processes.
Understand diagrams, schematics, assembly drawings, fab drawings, and mechanical component drawings.
Recommend and implement RMA process workflow improvements.
Dispose of bio-hazardous material as required.
Perform "Purging tasks" for all completed RMAs if applicable.
Maintain knowledge of DOPs, SOPs, and MPIs pertaining to I/A RMA operations.
Work independently towards daily and throughput targets.
Follow all corporate, safety, SOP, DOP procedures, and regulations.
Maintain a clean and orderly work area.