Summary

Primary duties for the position are to evaluate endoscopes and light cables returned for service according to standard policies and procedures and entering the evaluations into SAP.

• Produce and maintain production records
• Notify proper personal regarding manufacturing materials performance
• Properly complete all required documents
• Clean and maintain personal and general work areas

100% onsite in Charlton, MA 6-2:30 Mon-Fri

Onsite interview

Day-to-day activities of this role:
​150 to 160 endoscopes/week returned for various reasons; this team performs a thorough evaluation on each item, providing and documenting a comprehensive assessment for regulatory and pricing purposes.
​Dirty room, devices have been used on patients, PPE, lab coat, nitrite gloves, safety glasses provided by KS, as is training
​There is a high level of oversight on this process. Because you are assigning a price, the report must be accurate and detailed for customer and regulatory review.

30-90 min assessment time per unit

​75% time sitting, 25% moving between workstations
​Must be able to follow instructions/directions/checklists; cleaning protocols
​Must have computer skills, be able to work efficiently, to quality standards
​MUST have strong communication skills - written and verbal


SAP preferred but not required

Responsibilities

DUTIES AND RESPONSIBILITIES:

• Perform evaluations on at least one type of returned devices and document in the appropriate information is SAP
  
• Process Product Evaluation Reports for a minimum of one device type within compliance expectations
  
• Decontaminate returned devices using documented practices.
  
• Upload product evaluation information into SAP as needed. Disassemble and reassemble endoscope after evaluation as needed.
  
• Scans scope documentation and upload information into SAP as needed.
  
• Internal and external customer question resolution through appropriate processes and systems.
  
• Inspect the evaluations of other team members for quality control.
  
• Facilitate Evaluation functions with the warranty and complaint team.
  
• Actively participate in company sponsored training programs up to and including facilitating training as appropriate to role.
  
• Aware of practices and processes utilizing current management tools.
  
• Support data entry of evalautions and movement of inventory to appropriate repair locations as required.
  
• Create a complete and comprehensive Product Evaluation Report for the end user, complete with pictures as required.
  
• Makes a financial decision based on evaluation findings and ensures accurate entry of damage levels for distribution and the external customer.

ENVIRONMENT, HEALTH AND SAFETY:

• Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations, including the Companys environmental and safety policies and procedures. Must be willing to report actual and potential environmental and safety violations to appropriate supervisory and/or management personnel.
• The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001.
• Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others.
• Responsible for informing the Company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties.
• Other specific safety responsibilities include proper use of personal and departmental safety equipment.
• Specific safety hazards associated with this job include the handling of solvents, chemicals and adhesives.
• All workers in The Evaluation Center could potentially be handling bio-hazardous material, and proper safety procedures should be followed at all times. Proper Personal Protective Equipment and clothing will be required for certain tasks and locations.

QUALITY

The incumbent in this position is responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, ISO 13485 (current revisions).

Requirements

PHYSICAL REQUIREMENTS


• Must be able to work overtime as needed.
  
• Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
  
• Excellent manual dexterity and keen vision with the ability to pay close attention to details.
  
• Must be able to work with a microscope for extended periods of time.
  
• Must be able to work with hand tools and measuring instruments.
  
• Must be able to stand for extended periods of time.

MENTAL REQUIREMENTS

• Must be able to keep up in a fast-paced environment.
  
• Must be conscious of safety around bio-hazardous material.
  
• Must be able to process product with safety, efficiency, and quality as high priorities.
  
• Must be able to learn new processes and procedures quickly.
  
• Must be able to make decisions that affect coworkers and product quality.

INTERPERSONAL AND COMMUNICATION SKILLS

• Must be able to maintain productive working relationships with coworkers.
• Must treat fellow employees with respect.
• Individual must daily communicate with coworkers to inform others of work status.
• Must have neat and legible handwriting to produce daily production records.
• Individual should communicate proactively with management suggesting ways to improve products and processes.
• Ability to perform as a team member.
• Interact with different personalities throughout the organization


MINIMUM KNOWLEDGE, AND SKILL REQUIREMENTS

• 0 - 2 years experience in an evaluation or in a manufacturing role where quality is essential to the product
• Able to use basic measurement tools for both dimensional and visual evaluations preferably in a medical device manufacturing company.
  
• Able to perform transactional/data entry based computer skills required.
• Must be able to work well with coworkers.
• Able to apply substantial understanding of evaluation techniques, disassembly and re-assembly.
• Able to perform/has ability to learn a wide range of evaluation tasks.
• Able to perform basic data entry of text into SAP and experience with MS office.