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Senior Quality Systems Specialist
Job Number: #2017-15
Location: St. Paul, MN

EnteroMedics is looking for a Sr. Quality Systems Specialist who will be responsible for the implementation and maintenance of elements of an FDA QSR and ISO 13485 compliant quality system. Administers critical functions of the Quality Management System including the document management, training, calibration, and the company safety program. Support regulatory submissions and operations as required.

ESSENTIAL FUNCTIONS

  • Coordinate and administer New Hire Training Program for Quality Systems. This includes working with management to establish requirements, maintaining training materials, delivery of training, and ensuring appropriate documentation is completed.

  • Facilitate the document management and change control system in accordance with the EMI procedures. This includes serving as the change coordinator in the electronic document management system and assisting users with document management activities.

  • Support administration of the eQMS software (Grand Avenue System) to support the QMS needs.

  • Manage the EMI CAPA system ensuring compliance to the EMI process.

  • Provide support activities to Supply Chain with regard to maintenance of the Approved Supplier List.

  • Serve the role of the Audit Program Coordinator. This role is responsible for managing the Internal Audit Program. Interfacing with third party auditors both the Notified Body auditors and the contracted internal auditors. Conduct internal audits when applicable such as the clinical research process.

  • Serve as the Calibration Coordinator. Coordinate the Calibration and Preventive Maintenance Program including assigning equipment numbers, maintaining the equipment list, scheduling calibration suppliers, and reviewing calibration certificates.

  • Serve as the Standards Coordinator. Manage the External Standards program, including performing annual standards review, working assignment and tracking of change assessments, and ensuring currency of the standards database.

  • Provide support for the development, submission, and maintenance of regulatory filings as required.

  • Lead the facility safety program including performing audits, delivering training, performing/scheduling safety related maintenance projects, and maintaining records.

  • Contribute to the development, analysis, and production of metrics to monitor and improve the quality system and support management review.

    MINIMUM REQUIREMENTS

  • Bachelor’s Degree in technical field. (Appropriate experience may be substituted for degree.) Position may be modified for personnel with exceptional qualifications

  • 7+ years’ experience working in the medical device industry, preferably with active implantable devices.

  • Working knowledge of FDA QSR and/or EN ISO13485

  • 4+ years’ experience implementing and maintaining elements of a quality system, including CAPA, internal/external audits, nonconforming material, management review, document control, training, and/or calibration.

  • Auditor experience desired (CQA or other auditor certification preferred)

  • Experience with electronic QMS or PLM systems required. Experience with Grand Avenue Software preferred.

  • Excellent verbal and written communication skills

 If you are interested in applying for this position, please fill out this form to submit your resume.