SanaHeal, Inc.

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Quality Engineer

Engineering

Full Time

Cambridge, US

Posted 2 weeks ago

About the Job

Salary - $110000 - $120000/Year

SanaHeal is looking for an innovative, talented, and self-motivated QA / RA Engineer enthusiastic about the development and commercialization of breakthrough bioadhesive technologies. The successful candidate will work with the team to support regulatory, QA / QC, and compliance processes of novel tissue adhesive biomaterials and medical devices for the repair and healing of diverse tissues and organs. The ideal candidate should have good communication skills, teamwork capability, and timely implementation of QA / RA activities in a fast-paced startup environment.


 

Responsibilities


  • Develop and perform product testing to support regulatory filings
  • Develop and implement quality assurance and quality control protocols for PMA and 510(k) products in close communication with regulatory management
  • Assist in developing and implementing QMS / document control systems
  • Effectively communicate outcomes through technical reports
  • Serve on product development teams to develop products in compliance with FDA regulations and other standards
  • Support FDA regulatory process and compliance for PMA surgical and 510(k) wound products in close communications with regulatory management
  • Interface with and manage contract manufacturer(s) and other suppliers
  • Serve as Management Representative



Qualifications



  • BS in an engineering, science, or regulatory discipline
  • Minimum 5 years experience in medical device / biomaterials industry, including product quality assurance and control, product regulatory compliance and documentation
  • Strong knowledge of ISO 13485, US FDA 21 CFR 820, and US product approval processes
  • Knowledge of EU MDR and CE Marking is desirable
  • Knowledge of material science, biopolymers, and implantable materials/devices is desirable
  • Experience with medical device development and regulatory clearance


Posted 2 weeks ago

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