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QUALITY SYSTEMS ENGINEER

QUALITY SYSTEMS ENGINEER


QURA is engaged in developing a wireless implantable pressure sensor and data management system.

We have an immediate job opening for a Boston area based Quality Systems Engineer / Manager. Looking for someone to start in a consulting role at about 30 hours/week for a period of 4-6 months, then move to full time employment with standard company benefits.

JOB DESCRIPTION:

  • We have an exciting opportunity for a Quality Engineer to work with a young company that promotes smarter medicine capitalizing on disease intelligence through a breakthrough in bioengineering and medicine.
  •  This position will be responsible for implementation of quality systems supporting design, testing  and effective manufacture of implantable pressure sensors, compliance with internal procedures and external regulations, and the efficient execution of business activities there to related.

RESPONSIBILITIES

  •  Implement a quality management system
  • Manage company documentations regarding quality
  • Monitor and ensure compliance to internal quality system and external industry regulations
  • Execute and support activities to ensure effective monitoring of compliance to quality system by suppliers.
  • Develop and maintain inspection and quality control procedures
  • Perform activities pertaining to supplier audits, i.e. audit plans, audit execution, audit reports
  • Manage supplier changes and work with engineering to implement changes in standard operating procedures

JOB REQUIREMENTS

  • Minimum Bachelors degree in engineering, life science or related discipline
  • At least 3 years Postbaccalaureate work experience

Prior experience in quality management of medical devices, either in Product development, Manufacturing or Quality Assurance

Familiarity with quality systems (ISO 9001:2015 quality systems), including ISO 13485:2016 & 21 CFR 820 for medical devices

Demonstrated knowledge of statistical methods and principles

Ability to create and maintain project plans

Excellent verbal and written communication skills

Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines and standard practices, and ability to function as a part of a team

Outward directed, goal (rather than process) oriented

Ability to handle complexity

  • Some travel to vendors, suppliers and research partners may be required

ABOUT QURA:   Elevated baseline intraocular pressure (IOP) and large transient fluctuations of IOP are strong risk factors in the development and progression of glaucoma, a leading cause of irreversible blindness.  Based on patented technology, Qura is developing the first implantable active, wireless continuous IOP sensor for monitoring glaucoma progression.  The miniaturized device provides for uninterrupted twenty-four hour monitoring of intraocular pressure (IOP) in the anterior chamber, or any other site inside the eye, as desired by the surgeon.  Twenty-four-hour monitoring of IOP will drive a change in glaucoma management and facilitate timely and targeted medical or surgical intervention by the cataract and glaucoma specialist.

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