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Title: Sr Manufacturing Quality Engineer
Hiring Organization: Connexion Systems & Engineering

• Duration:  PERM
• Pay rate: $120-140k
• Job Location: Tewksbury, MA
• Job# 16220

• Provide quality engineering support in the manufacturing of medical devices & hardware.
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
• Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.
• Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.
• Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
• Oversee the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards.  Establish and maintain quality control procedures, including inspection methods and test protocols. 
• Resolve incoming inspection yield issues by driving tighter vendor process capabilities, ensuring appropriate internal drawing specifications, and validation of inspection methods. 
• Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)
• Support internal auditing requirements in manufacturing to ensure compliance with quality system requirements. 

• Minimum of 8 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering 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.

• Experience with manufacturing of complex products in an Environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.  
• Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
• Experience with handling non-conforming material and assemblies.
• Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding & application of Gage R&R and Measurement system analysis desired.
• 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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