Medical Device Quality Engineer

posted:
Location
Plymouth, Massachusetts
Industry
Engineering (Architecture and Engineering Occupations)
Job Type
Full-Time
Salary
US$ 75,000 - US$ 100,000 per year, $75k - 100k per year + none
Ref. Number
S_27213
Contact
Duggan,Julie, Spherion
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Job Description

Spherion is actively recruiting for a Quality Engineer experienced in Medical Devices for a client in Plymouth, MA!

Responsibilities Include:
Establish and participate in supplier qualification/development activities.
Lead/Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.
Lead/Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance.
Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.
May ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team.
Perform analysis of reports and production data to identify trends and recommend updates to changes to the Quality System Regulations, Standards, and/or guideline procedures when necessary.
Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.

Working hours: Monday-Friday, office hours TBD

Skills:
Requirements Include:
Thorough knowledge and experience surrounding quality control inspections
Previous Medical Device experience(5-8 years) in a quality role.
Thorough knowledge of ISO 9001 and ISO 13485 standards and FDA 21 CFR part 820
Minimum Bachelor's Degree in an Engineering or Science discipline
Green Belt or ASQ certification a plus.
Proven problem solving experience including 8D.

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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