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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 responsible for development, implementation, and ongoing maintenance of significant elements of an FDA QSR and ISO 13485 compliant quality system. Manages critical functions of the Quality Management System including the EMI document control system, the EMI training program, the calibration system, and the safety program. Support the regulatory submissions as required.

ESSENTIAL FUNCTIONS

  • Develop and implement major elements of a FDA and ISO compliant Quality Management System including training

  • Coordinate and administer the New Hire Training Plan process of the Training Procedure. This includes completing new hire quality and documentation systems training and follow up with supervisors to assure that the New Hire Training Plan in completed and filed. Ongoing training of new hires and established personnel in Quality Systems.

  • Manage the document control system. Ensure that all critical EMI documentation meets the change control process.

  • Administer the Grand Avenue System to support the QMS needs. Manage the EMI CAPA system ensuring compliance to the EMI process.

  • Provide necessary support activities to Supply Chain in regard to the Approved Supplier List. Conduct supplier audits as required.

  • 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 the role of the Calibration Coordinator. Coordinate the Calibration and Preventive Maintenance Program. This involves the calibration of approximately 240 pieces of electrical and mechanical equipment.

  • Complete the annual standards review and keep the EMI standards library current. Support the development, submission, and maintenance of regulatory filings.

  • Manage the facility safety program and conduct the required safety audits. Drive Safety Training including scheduling consultation with outside safety experts for safety program development as well as safety related maintenance projects such as emergency shower/eyewash, safety glasses, electrical safety equipment and hazardous chemical identification/storage.

  • Ongoing maintenance of systems, including executing actions, reporting and analyzing data and continually improving the system. Cooperating with other groups within the department and company to optimize the system, meet internal customer needs and ensure compliance.

MINIMUM REQUIREMENTS

Bachelors Degree in technical field and 5+ years experience in Medical Device Quality Systems, preferably with active implantable devices. CQA or other auditor certification preferred. Position may be modified for personnel with exceptional qualifications.

Experience developing, implementing and maintaining multiple major elements of a quality system and an detailed knowledge of FDA QSR and ISO 9001:2008 and/or 13485, including CA and PA, Audits, NCM, Management Review, Document Control, Identification and Traceability.

Superior and demonstrated policy, procedure and work instruction writing skills as well as excellent communication and training skills

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