Quality Engineer

Massachusetts, Lowell

Posted: 01/25/2019 Industry: Engineering Job Number: 12625 Pay Rate: $58.00

Our client, a large medical device manufacturer located in Acton, MA, has an immediate opening for a Quality Engineer for a 6+ month contract

ESSENTIAL DUTIES AND RESPONSIBILITIES:
-Supports validation and risk build activities with manufacturing and engineering group
-Leads Customer Complaint Investigations
-Responsible for customer complaint product dispositions
-Performs root cause analysis and implements effective corrective action for customer complaints and CAPAs
-Assess quality performance using statistical and analytical methods
-Initiates non-conforming dispositions
-Initiates CRs and COs
-Develops and implements test methods and procedures for inspecting, testing and evaluating product and processes
-Develops gauging methodology for products
-Performs capability studies and gage R&R
-Reviews and approve calibration records
-Continuously identifies areas of improvement in the manufacturing processes that would enhance product quality and partner with manufacturing to implement the improvements
-Conducts trend analysis: collect data, create, update & maintain trend charts and reports
-Analyzes improvement opportunities through MRB monitoring
-Supports Quality Improvement Coordinators to ensure products & processes comply with regulatory and QSM requirements
-Develops trainings to build quality awareness
-Reviews and approves risk management/risk analysis documents
-Participates in PFMEA and DFMEA reviews
-Participates and provides input in design review meetings, partnering with NPD and Manufacturing during the entire development and transfer process
-Supports manufacturing and engineering to resolve technical issues

EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
-Bachelor s degree in Engineering or a technical field preferred
-3+ years of experience responsible for Quality improvement projects preferred
-2+ years of experience in a regulated industry experience that includes FDA and ISO requirements preferred
-ASQ certification a plus
-Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions
-Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and/or Canadian Medical Device Regulations
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