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Quality & Regulatory Specialist

  Boston,   $60ph - $80ph

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  Quality    Permanent

Position Summary

This is a Quality Engineering opportunity with a start up that spun out of Harvard Medical, developing awesome technology in a collaborative effort with Doctors Without Borders. An initial 6 month temp-to-perm remote position offers the chance to work with some of the brightest people in Boston on a technology that's going to revolutionize disaster relief!

Principal Duties and Essential Functions:

  • Maintain Quality Database and all ISO documents under ISO:9001 and ISO:13485
  • Lead quality process improvement projects and participate in management reviews
  • Assist in customer, ISO, and FDA audits Customer Quality Assurance Plans
  • Assist in development and implement Quality Plans
  • Work with QM to ensure that action items are effectively completed and audited

Required Qualifications/Skills

  • Bachelor’s degree or equivalent experience required
  • Minimum 5 years in Quality Management with previous Medical Device ISO:13485 experience.
  • Technical Quality Systems knowledge including Statistical Process Control (SPC), Quality Function Deployment (QFD)
  • Experience with medical product manufacturing (GMP, BPR, FMEA, Risk Assessment)
  • Working knowledge of ISO 9001, ISO13485 and FDA regulations
  • US Citizenship or Green Card holder

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.


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