Job Details

  • Title: MDR Remediation
  • Code: RCI-28899115
  • Location: Saint Louis Missouri (MO) 63122
  • Posted Date: 11/27/2019
  • Duration: 1 Years
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  Job Description

MDR Remediation – Technical files and Risk Management

Job Description:


MUST HAVEs
- Medical device professional who has quality experiences international Quality System Regulation (QSR) standards.
- System Regulation, ISO 13485, ISO 14971, EN 62366-1, and EN 62304.
"Preferred
• Medical Device Regulations (MDR) readiness,
• Medical Device Single Audit Program (MDSAP) readiness,"

Required
• Proven ability to establish collaborative working relationships to review and approve deliverables that meet quality system requirements.
• Problem solving and decision-making paths for continuous quality related processes
• Provides design control leadership and guidance to peer members of the team.
• Medical Device design control remediation using applicable regulatory requirements.
• Systemic understanding of the flow of information through the quality system deliverables.
• Foundational understanding of System Regulation, ISO 13485, ISO 14971, EN 62366-1, and EN 62304.
• Practical understanding of the product lifecycle for risk management including Risk Management Plans, Risk Analyses, failure modes and effects analysis (Design FMEA, Use FMEA and Process FMEA), risk management reports.
• Detail-oriented understanding of how risk controls drive updated to design inputs, design outputs (including labeling), design verification and design validation.
• Proficient use of MS Word, Excel, and PowerPoint
• Strong technical writing skills and has authored quality system documents (e.g. SOPs, Work Instructions, design control records) and/or refined quality system document to meet new quality system requirements.
• Working knowledge and experience with development procedures and processes, including design control.
• Provide technical input to quality processes for improvement of risk management, design controls, usability engineering.
• Demonstrated management ability including effective listening, employee selection, development, motivation and performance.
• Proficient use of document control systems for example ePDM, Documentum
• Proficient use of design change control systems for example ClearQuest, Kintana systems.

Provide the following information with submittals

Experience in the following systems or relatable systems:
• Proficient use of document control systems for example ePDM, Documentum
• Proficient use of design change control systems for example ClearQuest, Kintana systems.