Medical Quality Engineer – Plastic Injection Molding

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Company Name
Location
Greater Harford, CT
Posted On
August 30, 2021
Function
Industry
Job ID
2572
Compensation Range
$90,000+
Region
Northeast

Description

Medical Quality Engineer – Plastic Injection Molding 

Maintain our ISO 13485 registration and support all phases of our medical products lifecycle. Seeking Quality Engineer with medical plastic injection molding experience. Highly competitive compensation and relocation assistance.  

About This Job 

  • As Quality Engineer, be responsible for ensuring the manufacturing and support activities of medical devices produced to meet the requirements of ISO 13485 and other applicable regulations and standards.  
  • Maintain our ISO 13485 certification.  
  • Support program management and operations through all phases of our medical products lifecycle. 
  • Involvement with the ISO 9001 Quality Management System / IQMS Quality module and internal audit process. 

About This Company  

  • Over 30 years of innovative custom injection molded solutions in various end markets (medical, consumer, industrial goods). 
  • Specializing in 2-Shot thermoplastics and liquid silicone molding (LSR), using the most advanced technologies to deliver the best molding solutions to its customers. 
  • Consistently awarded Top Places to work in Plastics News and in its community, our client prides itself on delivering honesty, integrity, and value to every customer they serve. 
  • The company is both ISO 9001:2015 and ISO 13485:2016 certified. 
  • Commitment to safety and conducting business in an ethical, legal and socially responsible manner. 

Minimum Job Qualifications 

  • Minimum 2 years experience as a Quality Engineer in the medical device industry. 
  • BA/BS degree in science, engineering or other technical field highly preferred. 
  • ISO knowledge and training (ISO13485 and ISO 9001) preferred. 
  • Metrology skills – GD&T. 
  • Experience participating in internal and external audits preferred. 
  • Experience with CAPA, complaint investigation, field action processes and risk management. 
  • Basic knowledge of injection molding processes. 

 

 

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