Senior Quality Engineer

2 weeks ago

Tempe, United States GT Medical Technologies, Inc. Full time
Job DescriptionJob DescriptionDescription:

Position Summary

The Senior Quality Engineer develops, implements, and improves commercial product quality requirements, and is committed to improving the quality of patient care and improving the effectiveness of the quality management system. As a high level and hands-on resource, this position leverages medical device experience to lead in change control, product and process verification, and validation and supplier quality activities.


Job Duties/Responsibilities

  • Leads in process verification and validation activities including the development of the master validation plan, equipment qualifications (IQ/OQ/PQ), process performance qualification and sterilization validation.
  • Establishes requirements specifications to support in the qualification of capital equipment.
  • Develops validated test methods through attribute agreement or gage R&R studies
  • Writes, reviews and approves technical protocols/reports in support of verification and validation activities.
  • Establish risk based sampling plans based on a valid statistical rationale and identify statistical techniques for verifying the acceptability of process capability and product characteristics
  • Lead root cause analysis activities to correct issues found during verification and validation activities.
  • Maintains the risk management file and design history file throughout product development projects
  • Ensure assigned quality processes and procedures are compliant with FDA, GMP, ISO and other applicable standards and regulations.
  • Manage the selection, qualification, and certification of responsible suppliers to support manufacturing and product development. Maintain the associated Approved Supplier List (ASL).
  • Conducts supplier quality audits (prepares audit plan and final report)
  • Develop process validation plans and reports to demonstrate the supplier’s capability to meet product component requirements. Develops incoming inspection requirements based on supplier’s capability
  • Supports nonconformance corrective actions and issues supplier corrective action requests (SCAR) as needed.
  • Provide support to the regulatory department in writing technical submissions
  • Embodies the Company’s purpose and shared values, building a positive and productive team culture.
  • Comply with Company policies and procedures.
  • Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
  • Other duties as assigned.
Requirements:

Qualifications

  • BS in Engineering from an accredited college or university or relevant education and experience.
  • Minimum of 5 years of experience in an engineering role in the medical device industry.
  • Working knowledge in statistical analysis techniques.
  • Experience in test method strategies, development and validation including Gage R&R and PPAP.
  • Experience with risk management methodology.
  • Experience in process development and process validation.
  • Experience leading Lean and Six Sigma projects with high degree of technical complexity.
  • Lean Six Sigma Black Belt Certification preferred.
  • Experience with sterilization methods, or nuclear materials preferred.
  • Experience regulations and standard in support of medical device projects (FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971, ISO 11135).
  • Experience conducting quality audits.
  • Certified Lead Quality Auditor Certification preferred.
  • Ability to create and manage key internal and external partnerships.
  • High level of attention to detail.
  • Ability to demonstrate proficiency in issue resolution.
  • Ability to manage multiple priorities with little direction.
  • Familiar with product safety standards.
  • Demonstrated Project Management skills.
  • Excellent written and verbal communication skills.
  • Proficient in using Microsoft office programs (Word, Excel, Outlook, and PowerPoint).
  • Able to travel for work as needed.
  • Satisfactorily pass comprehensive background screening.

Physical Demands/Working Conditions

  • Typical work environment for a professional office or home office space and occasionally works in a laboratory, supply room, and/or clean room environment.
  • Largely a stationary role with some moving from place to place.
  • Constant use of a computer, keyboard, mouse, monitor and other office equipment.
  • Occasional use of laboratory equipment.
  • Requires some finite hand/eye coordination.
  • Occasionally picks up, carries, and moves items up to 30 lbs.
  • Some evening and weekend work depending upon workload.
  • Some overnight travel may be required for work, events, and training.



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