LINQM is looking for someone for a 7 month project.

Skills: Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed. 

Key Responsibilities: Perform visual, dimensional, and functional inspection of components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications

Perform functional testing of finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications 

Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE.

Perform verification of manufacturing documents with component and device drawings 

May control inventory to ensure appropriate storage conditions and movement

May train colleagues from other sites, including inspection of their work output 

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

Color vision is required. A vision test will be administered as a part of onboarding.

Keywords:

Education: Education and Experience:

H.S. Diploma or equivalent required.

1-2 years previous related exp.  in a similar role in a regulated industry such as medical device, pharma, clinical etc. preferred Some experience inspecting finished goods preferred Familiarity with GDP (Good Documentation Practices)

Preferred Additional Skills: • Ability to use applicable tools and equipment, hand eye coordination, and high manual dexterity 

Basic level of understanding of inspection procedures 

Ability to effectively provide and accept feedback from colleagues

Good communication skills • Able to read, comprehend, speak, and write English 

Basic computer skills, preferred 

Strict attention to detail 

Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing