Job Description Summary

Job Description

Purpose

Assesses devices in-process and upon completion, reviews accompanying documentation, and conducts audits to ensure all comply with regulatory and company guidelines, and that devices meet operational standards as designed.

Job Function

Perform visual inspection across all components and devices using all applicable wide variety of tools and equipment to ensure conformance with design specifications, including participating in nonconformance investigations and process audits while working independently at the highest levels of productivity.

Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards.

Authorize the setup of line start up, verify compliance with established line set up procedures for packaging and labeling.

Perform functional testing of finished medical device products using both automated and manual valve testing equipment.

Work with cross-functional teams to investigate nonconformance issues.

Provide coaching and training to lower-level employees, evaluate and demonstrate correct approach on work of other employees.

On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.

Education/Experience

H.S. Diploma or equivalent

Technical degree in fields such as electronics, metrology, computer operations is preferred.

4 Years of previous related experience

Full level of understanding of inspection procedures, and ability to read and follow drawings, is required

Required Skills

• Strong skills required in:

o Communications and interpersonal

o Mathematics

o Analytics

o Computer utilization

• Able to read, comprehend, speak, and write English

• Ability to use applicable tools and equipment, hand eye coordination, and high manual dexterity

• Full understanding of applicable inspection procedures and/or drawings, including the ability to contribute to the development of procedures

• Proficient in all inspection techniques for production inspection

• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Strict attention to detail

• Must be able to work in a team environment and with minimum supervision by following detailed work instructions

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift