SQAFYI - Software QA Resource - FYI

US: Senior QA/RA Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 31-Mar-2015

Senior QA/RA Engineer


Provide Quality Leadership in the new product development arena Works with R&D engineers in a collaborative team environment ensuring all design control requirements are met Partner with New Product Development team in ensuring the Design Control procedures (SOPs/WIs/forms) meet the needs of the organization while ensuring compliance requirements are met. Works with supplier quality on decision making for new product/component acquisition ensuring supplier is capable of meeting new product development needs Works with Mfg personnel and Receiving inspection personnel to ensure internal and external requirements are being met. Continuously identifies areas of improvement in nonconformance process for efficiency and compliance Identify opportunities to improve product quality and partner with manufacturing and other functions to implement the improvements Conduct data trending and submit report Analyzes improvement opportunities Supports Quality Improvement activities to ensure products & processes comply with regulatory and QSM requirements Develops trainings and train for creating quality awareness Supports manufacturing and engineering in root cause investigation for defects originating from nonconformance process Assist in ensuring validation processes are implemented as needed (IQ, OQ, PQ)


Bachelors of Science in an Engineering or Science discipline and/or equivalent work experience 10-12 years minimum experience in Medical Device Industry Management or project management experience a plus Product Software experience preferred Able to effectively communicate complex business, technical and organizational issues to a broad audience. Able to interpret and understand integrated business plans and supporting financial models. Able to maintain personal and professional integrity under stress. Able to reduce complex technical issues to actionable tasks and then to successful outcomes via personal action or delegation to an extended team member. Excellent analytical problem solving ability. Experience in supply base management including negotiation and working knowledge of key business terms affecting Hill-Rom total cost model. Formal training in progressive management techniques. Proven results leading challenging engineering related projects Solid understanding of manufacturing cost accounting and finance.

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Thank you,
Team SQAFYI - Software QA Resource FYI

US: Senior QA/RA Engineer