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Quality Systems and Regulatory Compliance Engineer

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Job Type
Direct Hire
Bachelor of Science
May 17, 2017
Job ID
Quality Systems and Regulatory Compliance Engineer
Main Objective:
Responsible for supporting the Quality Systems and Regulatory Compliance (QSRC) Manager with all quality related support for improving and maintaining the global Quality Management System (QMS) to ensure compliance with FDA QSR, ISO 13485, and all other applicable regulatory requirements.
Essential Duties and Responsibilities:
  1. Responsible for participating in QSRC projects and assuring the QMS meets all requirements.
  2. Responsible for reviewing root cause analyses, effectiveness review plans and NC/CAPA documentation for QMS compliance.
  3. Work with QE’s to improve quality and assist, where necessary, in CAPA investigations.
  4. Train and/or assist QSRC Manager in the training of QE’s and Subject Matter Experts (SME’s) on QMS procedures, root cause analysis, effectiveness review planning and QMS software/programs.
  5. Participate in Internal and External quality audits as directed by the QSRC Manager.
  6. Responsible for assisting in maintaining External Audit files in accordance with established procedures and SOPs.
  7. Responsible for writing and/or assisting in the writing of QMS SOPs.
  8. Responsible for assisting/leading NCR or CAPA investigations.
  9. Responsible for assisting in compiling and reporting on QMS / Compliance metrics.
  10. Responsible for writing and/or assisting in the writing of audit responses, both Internal and External.
  11. Other duties as assigned
 Education and Experience:
Bachelor’s degree required in an Engineering discipline.  At least three years experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of testing equipment, statistical methods, control plans.
Experience in leading CAPA activities, specifically root cause analysis and effectiveness review planning.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), Agile, SAP or similar inventory software as well as CAPA, NCR, Audit or Complaint Management software.