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Quality Engineer in Brooklyn Park at Collabera

Date Posted: 9/19/2018

Job Snapshot

Job Description

• Provide Quality Engineering support to product development and inspection teams for Electro-Mechanical device. Provide support for Final Design Freeze and Product Release.
• Support the incoming inspection department and in-process inspections where required.
• Review component qualifications and validations to support key development and continuous engineering projects.
• Approve key deliverable in support of product launch, which include: component qualifications, design and product risk assessments, shelf life validations, and sterilization validations and more.
• Work with R&D engineers and Inspectors to prepare material specifications, and inspection documentation for new products.
• Set inspection requirements, set inspection methods and inspection sampling plans.
• Assist with non-conforming materials, including supplier contact and maintenance.
• Expertise in ALM, preferred.
• Working knowledge and understanding of mechanical drawings.
• Strong problem solving and technical writing skills.
• Sitting/standing 8 hours per day. Light lifting may be required on occasion.
• Ability to work under a microscope.

Job Requirements

• B.S. degree in Engineering or equivalent experience preferred.
• Must have working experience of GMP and ISO 13485 requirements.