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Sr Specialist, Quality Systems

Tewksbury, MA

Posted: 11/13/2023 Industry: Engineering and Technical Job Number: 16219

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Title: Sr Specialist, Quality Systems
Hiring Organization: Connexion Systems & Engineering

  • Duration:  PERM
  • Pay rate: $110-140k
  • Job Location: Tewksbury, MA
  • Job# 16219

  • Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances. 
  • Evaluate, trend and triage issues that may be considered Corrective and Preventive Action (CAPAs).  
  • Facilitate product and process CAPA investigations from issue identification through implementation of solution and effectiveness monitoring. 
  • Facilitates NCMR trending & CAPA Review Board (CAB) meetings. 
  • Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines. 
  • Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
  • Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques
  • Data Analytics (KPI): Leverage analytical tools to deliver solutions that help solve business problems (Power BI, SharePoint Online, Excel, etc.). Deliver ongoing reporting & analytics of KPIs to the SR Leadership Team and for CAB meetings.
  • Minimum of 8 years’ experience in a Manufacturing Quality and/or Quality Systems role, with 4 years’ responsibility for Product Quality and/or Quality Systems.
  • Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.
  • Functional knowledge & experience of effective root cause investigation, corrective and preventive action planning, execution, and verification of effectiveness techniques. Experience with quality tools and process improvement techniques.
  • Experience with manufacturing of complex products in an Environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.  
  • Utilization of statistical data analysis for trending purposes; ideally Six Sigma methods and tools
  • Ability to communicate ideas and information clearly, effectively, and concisely.  

EDUCATION: BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.

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