Quality Systems Medical Device Consultant
The Quality Engineer Consultant will lead (primary ownership) or support (secondary ownership) Quality Systems remediation, including;  investigations, Medical Device Reporting (MDR), Complaints, CAPA, Non-Conformances (NCR), Change Controls, Production &amp; Process Controls, and Risk Management as assigned. Additionally, will lead improvements to the aforementioned Quality Systems as assigned. To achieve goals, experience in the development and/or manufacturing of Medical Devices or Pharmaceutical products is required. Strong knowledge of Quality Systems in an FDA regulated environment is required. Direct Knowledge and experience working in Quality Assurance is preferred.QUALITY SYSTEMS MITIGATION ACTIVITIES:Utilize expertise in Risk Management to review and update FMEAs as needed. Review  validations and documents in the document management system to research content and material that are applicable to the FMEAs. Author change notices as needed.Assess production lines to determine where quality checks and process controls are needed. Utilize knowledge of statistical process control and test method validations to support the implementation of the necessary quality checks and process controls.Conduct and write formal MDR(s), Complaint Investigations, CAPA(s), Non-Conformance(s), or Change Control(s).Identify root cause and implement effective solutions that prevent event recurrence.As required, perform gap assessments and investigate to the depth commensurate with the identified risk.Analyze and organize data from multiple sources to support the weekly update and Management Review.The incumbent will be expected to make decisions based on risk using the following criteria: 1) Product’s safety and efficacy; 2) Regulatory risk; 3) Quality System Requirements. QUALITY SYSTEMS IMPROVEMENT RESPONSIBILITIES:As a member of the Quality Systems Improvement Team, defines the current state of the quality systems (as-is) through the development of process flow maps and data collected from the mitigation activities.Works with team to develop the improved process for all applicable Quality Systems and translates new model to corresponding process flow maps.Translates new processes into workable Standard Operating Procedures (SOPs).As required, pilots new procedures to ensure flawless deployment.Develops and executes validation protocols to completion and approval.Develops and provides training as required.Desired Skills and ExperienceA minimum of a Bachelor's degree in Engineering, Science, Technology or a related discipline is required, with a minimum of 10+ years experience in the medical device or pharmaceutical industries. Knowledge of statistical tools and techniques is required. Black Belt or Green Belt Certification is an asset. Thorough understanding of FDA’s Quality System Regulation (QSR), MDD, ISO, or Pharmaceutical regulation.Knowledge and proven application of Process Excellence/ Lean concepts are a differentiator.Demonstrated ability to multi-task, lead, communicate and deliver timely results.Experience with influencing at various levels in organization: operational to leadership team level.Works independently with minimal supervision once assignments or responsibilities are outlined and delegated.Ability to mentor at a technical level, and provide training when required.Excellent technical writing and verbal communication skills required. 
Title: Quality Systems Medical Device Consultant
Salary: None
Description: The Quality Engineer Consultant will lead (primary ownership) or support (secondary ownership) Quality Systems remediation, including;  investigations, Medical Device Reporting (MDR), Complaints, CAPA, Non-Conformances (NCR), Change Controls, Production &amp; Process Controls, and Risk Management as assigned. Additionally, will lead improvements to the aforementioned Quality Systems as assigned. To achieve goals, experience in the development and/or manufacturing of Medical Devices or Pharmaceutical products is required. Strong knowledge of Quality Systems in an FDA regulated environment is required. Direct Knowledge and experience working in Quality Assurance is preferred.QUALITY SYSTEMS MITIGATION ACTIVITIES:Utilize expertise in Risk Management to review and update FMEAs as needed. Review  validations and documents in the document management system to research content and material that are applicable to the FMEAs. Author change notices as needed.Assess production lines to determine where quality checks and process controls are needed. Utilize knowledge of statistical process control and test method validations to support the implementation of the necessary quality checks and process controls.Conduct and write formal MDR(s), Complaint Investigations, CAPA(s), Non-Conformance(s), or Change Control(s).Identify root cause and implement effective solutions that prevent event recurrence.As required, perform gap assessments and investigate to the depth commensurate with the identified risk.Analyze and organize data from multiple sources to support the weekly update and Management Review.The incumbent will be expected to make decisions based on risk using the following criteria: 1) Product’s safety and efficacy; 2) Regulatory risk; 3) Quality System Requirements. QUALITY SYSTEMS IMPROVEMENT RESPONSIBILITIES:As a member of the Quality Systems Improvement Team, defines the current state of the quality systems (as-is) through the development of process flow maps and data collected from the mitigation activities.Works with team to develop the improved process for all applicable Quality Systems and translates new model to corresponding process flow maps.Translates new processes into workable Standard Operating Procedures (SOPs).As required, pilots new procedures to ensure flawless deployment.Develops and executes validation protocols to completion and approval.Develops and provides training as required.Desired Skills and ExperienceA minimum of a Bachelor's degree in Engineering, Science, Technology or a related discipline is required, with a minimum of 10+ years experience in the medical device or pharmaceutical industries. Knowledge of statistical tools and techniques is required. Black Belt or Green Belt Certification is an asset. Thorough understanding of FDA’s Quality System Regulation (QSR), MDD, ISO, or Pharmaceutical regulation.Knowledge and proven application of Process Excellence/ Lean concepts are a differentiator.Demonstrated ability to multi-task, lead, communicate and deliver timely results.Experience with influencing at various levels in organization: operational to leadership team level.Works independently with minimal supervision once assignments or responsibilities are outlined and delegated.Ability to mentor at a technical level, and provide training when required.Excellent technical writing and verbal communication skills required. 
Requirements: Mid-Senior level experience, Bachelor's Degree education
Fraudulent: No