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Sr. Manager of Quality / Regulatory
Kenefick & Associates, Inc.
Job Location: New Haven, CT
The position of Sr. Manager Quality / Regulatory is with a very exciting, progressive, and growing Electronics Contract Manufacturing company. They assemble very high end and complicated circuit boards for the Defense, Aerospace, and Medical Device industries. The company is in a definite growth pattern thus presenting opportunity to progress. This position calls for a person to be responsible for implementation and maintenance of quality and environmental management systems including ISO 9001; AS 9100D, ISO 13485 , AND ISO 14001. Must ensure compliance to relevant FDA QSR'S and that the company is compliant with applicable regulatory requirements. You are responsible for ensuring that customer requirements are consistently met, cost of non-quality is managed, corrective actions and improvement initiatives are effective. Establish appropriate KPI's; Manage the CAPA system; see that there is a solid structure of problem solving for root cause determination and implement effective resolutions.You will lead a quality team of about 9 You MUST have : BS / Engineering Minimum of 10 years hands on experience in a manufacturing environment and proven Quality management system ovesight CQE / CQM Certification Experience in a regulated industry - Medical device, Aeropace, Defense Experience in Circuit Board manufacturing is a definite plus Lean / Six Sigma - Black Belt preferred Know ERP / MRP / MES Systems Proven ability to lead , mentor , coach and develop staff

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