Quality Engineer

New opportunity for a QUALITY ENGINEER with our client, a leading high tech group developing and manufacturing seals and implantable medical components for both Aerospace and Medical markets, that improve quality of life and safety in travel.

The Quality Engineer role ensures manufacturing processes, methods, equipment, and quality systems meet or exceed the requirements of our customers and 3rd party registrars. Establish consistent standards, customer specifications, and production goals.

The candidate we will present, much have the following:
Minimum Qualifications and Education Requirements

• Bachelor’s Degree (B.S.) in Engineering, preferably Mechanical, Electrical, or Chemical from an accredited college or university.
• 2+ years working experience in a manufacturing environment, preferrably in Aerospace/Medical Manufacturing environment
• ASQ-CQE Certification is desirable, but not required.
• This position requires access to technology, materials, software or hardware that is controlled by export laws of the US. Hired employees are required to provide proof that they are a U.S. Person as defined by 22 CFR §120.15 for ITAR requirements.
• This position requires use of Controlled Unclassified Information (CUI) which is subject to the International Traffic in Arms Regulations (ITAR), Export Administration Regulations (EAR), and Nuclear Regulatory Commission (NRC).

In this role you will be performing the following functions

• Update documentation, train and implement quality processes such as MRB, RMA, CAPA and NCMR.
• Direct MRB activities including facilitating MRB, tracking non-conformances and analyzing NCMRs and RMAs.
• Perform analytical investigations and develop root cause for non-conformances and deviations as identified through scrap analysis, NCMRs and RMAs.
• Responsible for maintaining CAPA database.
• Coordinate RMA process including approval, verification upon receipt, disposition and issuance of subsequent CAPAs. Respond to customer related SCARs as required.
• Issue, monitor and evaluate CAPAs for effectiveness and timeliness.
• Create and/or process ECOs, process routers, drawings and other written documentation in accordance with quality system requirements.
• Monitor supplier performance through scorecard/grading, analyzing RI measurement data (SQC) and tracking NCMRs. Perform supplier audits and visits as required.
• Maintain internal auditing program to sustain certification to ISO standards while maintaining the effectiveness of the system.
• Responsible for internal, 3rd party, and customer audits.
• Analyze data and generate reports from ERP data using Minitab and Excel.
• Responsible for internal quality audits per ISO 9001, ISO 14001, AS 9100 and ISO 13485.
• Create validation protocols (IQ, OQ, PQ) execute protocols and document reports when required. Assist in DOEs, ANOVA and other analytical methods to optimize processes.
• Develop, document and train inspectors using internal procedures and GD&T guidelines. Design/specify gauging and test equipment for inspectors.
• Implement and maintain SPC and SQC using Infinity QS.
• Develop quality plans, pFMEAs, and FMEAs for new and existing products. Assist with developing control plans and other documentation during new product development.
• Conduct capability studies and complete variation reduction activities to improve processes.
• Compile and write training material and conduct training sessions on quality tools & techniques.
• Create/update RI & Final Product MIR cards for product inspection and testing.
• Set up, program and operate CMM and SmartScope, as well as other measurement/inspection tools. Improve measurement techniques and detection methods using GRR, MSAs, and poke-a-yoke.
• Communicate effectively with production associates to understand issues/concerns and quickly move to countermeasure.
• Research and propose innovative documentation, training and inspection methods, including electronic record retention, automated visual inspection and inspector certification programs.
• Knowledge of Solidworks or AutoCAD is preferred.
• Perform various tasks as needed from supervisor.
• Conduct all tasks in a safe and efficient manner complying with all local, state, and federal EHS regulations and with Morgan New Bedford, MA EHS Guidelines. Guidelines include but not limited to participation in required EHS training and use of proper PPE. Employees are responsible for reporting hazardous conditions and job-related injuries or illnesses to their supervisor.