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Quality Engineer

Job Description Responsibilities:

Evaluate process development & validation deliverables for portfolio products for compliance to current quality system requirements
As needed, plan and guide the execution of Process and Equipment Characterization and Validation activities to remediate gaps in legacy product portfolios to meet current quality system requirements
Working with Project Management, establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader. Manage tasks and deliverables for multiple projects simultaneously
Evaluate equipment, tooling, fixtures and component materials for their ability to produce product per design specifications and compliance to the quality system.
Evaluate process characterization and investigations for documentation of key process inputs and outputs and to verify that appropriate process limits have been established
Direct R&D technicians in performing- equipment qualifications, process characterization and qualification builds.
Conduct test data analyses including identification of outliers or non-normal data, generating data plots, general statistical analysis, and determination of process capability.
Lead or participate in Failure Analysis, Root Cause investigation, and identification and verification of corrective actions. Report results to project and functional leadership Train PD technicians, production operators and manufacturing technicians
Mentor and direct PD Engineers and Technicians

Requirements:

Bachelor Degree in Engineering or physical sciences required 5 years of related experience required Successful track record of process selection, development, and transfer into commercial production
Experienced in process qualification and validation activities including risk assessment, range finding, DOE and creation of process documentation
Demonstrated project management skills and ability to coordinate multiple projects simultaneously
Excellent knowledge of GMP and QSR including Design Control and Process Validation.
Proficiency in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development cycle
Proficiency in MS Office applications, strong written and verbal communication skills, ability to read and understand technical drawings, product requirements and specification documents
Must have strong independent problem-solving skills and have sufficient understanding of statistical techniques to perform data analyses and process capability analyses (familiarity with statistical software such as Minitab preferred)
Excellent analytical and problem-solving skills, experience with scientific methods and Design of Experiments.
Preferred: 5 years of experience in medical device production or product development.
Preferred: Experience with common disposable medical device manufacturing processes (e.g. molding, reflow, coating, bonding, packaging).

: 22-02556 : Chelmsford, MA:

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