Work Shift: Monday-Friday3:30 pm to Midnight

POSITION SUMMARY

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

MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS

• High school diploma or equivalent experience.

• 1+ years' assembling miniature precision medical products or working with the evaluation of medical products.

• Must possess ability to understand product drawings.

• Must be able to work well with coworkers.

• Basic data entry of text into SAP and experience with MS office.

ESSENTIAL FUNCTIONS

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

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 both safety and efficiency 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.

DUTIES AND RESPONSIBILITIES: (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

• All employees are expected to be knowledgeable about and follow the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.

• Perform evaluations on endoscopes and document in the appropriate software including minors and Fiber and/or Video endoscope evaluations

• Disassemble returned endoscopes prior to decontamination

• Decontaminate returned endoscopes using documented practices.

• Enter completed evaluations in SAP

• Reassemble / close endoscope after evaluation as needed.

• Scans scope documentation and upload information into SAP as needed.

• 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.

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 Company's 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 and ISO 9001 (current revisions).

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

OTHER FUNCTIONS

OTHER DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

• 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.