Senior Quality Systems Engineer
Greatbatch Medical - Fort Wayne, IN

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Greatbatch Medical, located in Ft. Wayne, IN, is currently seeking a Senior Quality Systems Engineer. The primary purpose of this position is to assure site Quality System processes are established to produce a quality product and maintain compliance with applicable international quality standards.

Essential Functions of the Job
  • Developing and overseeing site quality system and compliance programs; serving as liaison with key notified body, regulatory agency, and customer auditors
  • Assuring site oversight of electronic quality management systems
  • Program responsibilities include, but are not limited to Management Review, Corrective and Preventive Action, Complaint Management, Internal Auditing, External Audit and Regulatory Inspection Management, and Document and Change Management
  • Provide management with quality system guidance
  • Guide the organization in the establishment of lean, effective, and scalable Quality System processes
  • Influence the organization to maintain compliance
  • Provide supervisory support and work direction as needed to site Quality Systems team members.
Position Qualifications
  • Education: Bachelor’s degree in related field. Masters degree strongly preferred
  • Experience: 7-10 years of experience. Application of ISO 9001, 13485 and QSR 820. Implementation and maintenance of quality systems. Project coordination. Business Process Black Belt strongly preferred. Lean training strongly preferred.
  • Specialized knowledge needed for performance of job: Computer skills as required by stated accountabilities. Experience supporting electronic quality management systems. Advanced word-processing and spreadsheet skills. Complex problem solving skills.
  • Special Skills: Demonstrated ability to lead team activities, strong ability to coach and advanced problem solving and root cause investigation skills. Strong communication, presentation, follow-through and organizational skills. Ability to work with and influence coworkers and all levels of the organization.