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Quality EngineerPosted by: Ativa Medica
Posted date: Dec-17-2015
Location: St. Paul, MN
Quality Engineer Position
We are seeking an experienced quality engineer to support routine operations and product development activities. In general, this engineer will be responsible for generating internal procedures, risk analysis documentation, assisting with verification strategy, and executing individual test plans and reports. In addition to these duties, the position will create inspection documentation for incoming materials and on-site production. They will review manufacturing documentation such as non-conforming material reports, manufacturing procedures, in process inspections, and special work orders.
Primary Duties and Responsibilities:
Qualifications (Knowledge, Skills & Abilities):
· Strong knowledge with industry standards (including ISO 13485 & 14971, FDA QSR)
· BS in Mechanical Engineering or a related field
· 3+ years of Life Sciences Industry experience
· Experience with statistical methods and terminology
· Effective oral and written communication skills
· Demonstrated organizational and administrative skills.
· Ability to prioritize and handle multiple tasks.
· Demonstrated problem-solving skills
· 3-5 years’ experience as a quality engineer in an IVD medical device environment
· Experience handling supplier quality