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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
LINQM was developed with the idea of “linqing” exceptional companies with top qualified professionals through a modern approach.