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Astrix Technology Group

Quality Engineer

Post Date:Apr 21, 2017Type:Full-Time
Start Date:4/21/2017Salary:
Location:US-OH-Columbus, OH Job Reference:


  • A Bachelor's Degree in Engineering or related technical field and a minimum of 5 years’ experience in a Quality Systems role 
  • Strong working knowledge of ISO 13485 and FDA Quality System Regulation (QSR) 21 CFR Part 820 
  • Experience successfully leading cross functional teams to execute against a timeline
  • Demonstrated conflict management skills
  • Excellent interpersonal skills
  • Experience in change control and change management
  • Demonstrated organizational and presentation skills
  • Accurate and attentive to detail
  • Demonstrated technical writing skills
  • Strong working knowledge of Microsoft Excel, PowerPoint, Visio, and Word


  • Experience in medical device design and development
  • Working knowledge of Pilgrim SmartSolve eQMS; Experience leading QMS design and/or ISO registrationCQE, or equivalent certification.
  • Familiarity with quality engineering concepts including: 
  • Risk assessment (DFMEA, PFMEA, UFMEA, etc.); Process capability and statistical process control; Tracking and trending of quality data
  • Root cause analysis, corrective and preventive action, and effectiveness verification;          Systems, methods, or product validation, or qualification 

Job Description:

We are currently seeking a Medical Products Quality Engineer to support Quality Management System (QMS) conversion efforts in support of ISO 13485:2016 conformance.


The Quality Engineer reports to the Quality System Manager and plans, directs, and implements appropriate QMS program changes to ensure conformance to ISO 13485:2016 to effectively and efficiently assure the quality of medical device and combination products from early feasibility and concept development through design and development, verification and validation, and clinical trial.  


  • Lead a cross-functional core team responsible for the remediation of Quality Sub-System(s) per ISO 13485:2016:
  • Evaluate conformance gaps
  • Establish vision and plans for future-state and present to stakeholders and top management; Develop timelines and hold team accountable
  • Communicate status to stakeholders, management, and resource groups; Create/revise appropriate documentation; Verify, route, implement changes to Quality System; Train staff to the updated requirements; Follow-up to assure effectiveness of training; Monitor/audit results
  • Supports audit(s): Aid in explanation of QMS conformance; Assist in evaluation, investigation, response, and corrective action for findings 

Contact Information
Astrix Technology Group
Name: Emily Holifield
Ph: 513-370-2525

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