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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:
Skills:

THE FOLLOWING QUALIFICATIONS ARE REQUIRED FOR CANDIDATE CONSIDERATION: 

  • 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

 THE FOLLOWING QUALIFICATIONS ARE DESIRED BUT NOT REQUIRED: 

  • 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.

PRIMARY FUNCTION

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.  

MAJOR RESPONSIBILITIES

  • 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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