Associate IPS Investigation Specialist

Job Summary

The Associate IPS Investigation Specialist will primarily deal with building competence in the daily tasks of an IPS Investigation Specialist I, with the intention of advancing to IPS Investigation Specialist I within a reasonable amount of the time. This position is primarily responsible for supporting the investigation of customer complaints (411s) related to IPS (Individual Patient Solutions) medical devices, operating within a regulated quality system environment. The employee will perform foundational investigative tasks in compliance with applicable regulatory requirements. The employee is expected to collaborate cross-functionally, including with Sales and Engineering teams, and to develop the skills necessary to take on increasingly independent investigative responsibilities over time.

Essential Functions, Duties, and Responsibilities

• Learn and demonstrate the ability to review and analyze customer complaints pertaining to IPS.
• Learn and demonstrate the ability to assist in day-to-day IPS complaint processing including intake, feedback review, dimensional analysis (3D scanning) of returned IPS products, and data logging.
• Learn and demonstrate the ability to assist teams with IPS complaint-related data requests.
• Learn and demonstrate the ability to assist Systems Engineering team in other related investigative duties.
• Learn and demonstrate the ability to coordinate with sales representatives to gather information necessary for complaint investigations.
• Learn and demonstrate the ability to assist with various related controlled documentation.
• Learn and demonstrate the ability to perform other related duties as assigned.

Education and Experience Requirements

• High school diploma with 4 years relevant experience, associate’s degree with 2 years relevant experience, or other equivalent combination of education and experience.
• Prior experience with SOPs, work instructions, and other controlled documentation preferred.
• Prior experience with root cause analysis preferred.
• Prior experience with complaint handling or quality systems in a regulated industry preferred.
• Prior experience with design and manufacturing processes for medical devices preferred.
• Proficient user of Microsoft Office applications.

Knowledge, Skills, and Abilities

• Adhere and support KLS Martin’s quality and safety policies and procedures.
• Able to work independently under minimal supervision.
• Strong interpersonal skills with the ability to effectively and professionally communicate at all levels internally and externally.
• Ability to create, maintain, retrieve, and interpret documentation.
• Ability to organize and summarize data using spreadsheets or databases.
• Ability to think critically and solve problems.
• Ability to learn new software quickly.
• Strong attention to detail.
• Proven adaptability & flexibility.