Quality Inspection Failure Analysis 3

About the role

The primary function of this position involves performing various inspections and tests on complex medical instrumentation, documenting findings in the Quality Management System, and managing Returned Merchandise Authorization (RMA) returns. This role requires a high level of attention to detail, problem-solving skills, and adherence to strict safety protocols.

Responsibilities

• 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.
• Performs failure analysis of defective instruments and accessories by evaluating the mechanical, electrical, and physical characteristics of returned items.
• Disposes of 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.
• Maintains a clean and orderly work area.

Requirements

• 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.
• 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.
• Able to communicate effectively with technical and non-technical internal customers.
• Acute attention to detail; excellent organizational skills.
• High level of professional integrity and ethics.
• Able to work varying shifts.
• 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 in a team environment.
• Ability to lift 50lbs.
• 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.

Qualifications

• 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.
• Communication Skills: Ability to communicate effectively with technical and non-technical internal customers.
• Attention to Detail: Acute attention to detail; excellent organizational skills.
• Professional Integrity: High level of professional integrity and ethics.
• Teamwork: Ability to work in a team environment.
• Physical Abilities: Able to lift 50lbs. 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 PPE usage.
• Other: Willing and able to work extended hours when necessary.