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JOB OPENINGS

Jr. Quality Engineer

Braintree, MA

Posted: 11/21/2018 Employment Type: Contract to Direct Industry: Engineering Job Number: 502515

Exciting temp to perm opportunity for a Jr. Quality Engineer who is enthusiastic and a self starter who can work independently as well as part of a team. 

  • Must have excellent organizational skills, ability to balance immediate vs. long term priorities and strong multi-tasking skills are a necessity. 
  • Requires strong writing skills.
  • Must have working knowledge of medical device quality system practices. 

Essential Functions:  

  • Plan, organize and implement various projects aimed at resolving product quality issues, making quality/compliance improvements to meet quality objectives
  • Develop and implement test methods, procedures and SOP’s to support Quality System activities
  • Assist with development of protocols, oversee testing and prepare reports as needed to support projects
  • Support Document Control in developing and maintaining Design History Files, Device History Records
  • Provide technical support for CA’s/PA’s, Risk Assessment, internal/external audit, complaints and verification/validation activities

Required Skills/Education:

  • Internship plus 1-3 years experience. 
  • Bachelors in engineering or science strongly preferred
  • Quality/Regulatory certifications desirable
  • Minimum of (1-3) years of experience in a medical device QA position preferably as a Quality Engineer
  • Some knowledge of regulatory/QMS requirements (FDA-QSR & ISO 13485) is preferable
  • Knowledge and understanding of sterile, single-use medical devices is desirable
  • Project Management skills
  • Experience with preparing protocols, reports, SOP’s and other documents
  • Knowledge and understanding of statistical techniques
  • Strong interpersonal and communications skills (oral & written)
  • Ability to work under pressure to react quickly to changing priorities
  • Considering Local qualified candidates only please

Benefits:

  • Multiple Healthcare Plans
  • Dental
  • Vision
  • Accident, Disability, Life
  • Direct Deposit/Pay Cards
  • 401(k)
  • Referral Bonuses

if interested please send resume to: dleblanc@summit-technical.com

 

 

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