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Validation Engineer *$1,500 Sign On Bonus*

Location: Vernon Hills
Posted on: May 14, 2022

Job Description:

Job Description*$1,500 Sign On Bonus*Richard Wolf Medical Instruments Corporation is currently seeking a Validation Engineer in Vernon Hills, IL. The Validation Engineer is responsible for coordinating and verifying quality standards in accordance with the requirements of the organization. REQUIREMENTS AND RESPONSIBILITIES:

  • Responsible for the validation of all required manufacturing processes in compliance with applicable internal and external requirements.
  • Coordinates manufacturing process validation requirements and documentation with internal and external stakeholders.
  • Supports the update and maintenance of validated processes
  • Supports validation training.
  • Builds, organizes, and maintains databases and/or logs of actions completed, pending actions, and current status
  • Provides reports and data on assigned metrics.
  • Creates and updates applicable procedures, work-instructions, forms, and other documentation as needed.
  • Participates and supports ECO, CAPA, MRB and other Quality System processes
  • Provides documentation and support during audits.
  • Complies with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820, GMP guidelines, GDP, ISO 13485, ISO 14971 and other regulatory requirements.
  • Manages multiple, often concurrent projects and meets deadlines.
  • Coordinates acquisition of cross-functional resources. ADDITIONAL RESPONSIBILITIES:
    • Aware of and complies with the RWMIC Quality Manual and applicable laws and regulations as they apply to this job type/position.
    • Completes all planned Quality & Compliance training within the defined deadlines
    • Other duties as assigned by Quality Assurance Manager or US Head of Regulatory Affairs – QA/QC. QUALIFICATIONS:(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
      • B.S. Degree in applicable technical discipline, such as mechanical, bio-medical or chemical engineering, required
      • Relevant experience or certifications demonstrating applied understanding of medical device quality system requirements, such asAAMI Quality System or sterilization certificates, Certified ASQ or ISO Lead Auditor and Regulatory Affairs Professional Society (RAPS) preferred
      • Applied understanding of statistical methods and tools, such as Six Sigma & Mini Tab required.
      • Excellent communication skills.
      • Advanced PC knowledge and working experience with spreadsheets, presentations and report writing tools.
      • Experience with and understanding of cross-cultural differences and the ability to work within this environment is crucial for successful employment.
      • The following physical demands are required:
        • Stand/Sit/Walk 8 hours per day
        • The following work environment conditions may exist:
          • Infectious Disease Exposure
          • Chemicals Exposure
          • RWMIC offers annual Immunizations for Hep B and Flu Shots to all RWMIC employees. RWMIC employees have the responsibility to themselves and the company to consider receiving these immunizations.
          • All RWMIC Employees have the responsibility to themselves and the company to work safely. We offer competitive wages and a comprehensive benefits package, which includes:
            • 401 (k) Retirement Savings Plan and Trust w/Matching Program
            • Medical Insurance, Dental and Vision Insurance
            • Company Paid Life & Disability Insurance
            • Paid Time Off
            • Paid Parental Leave
            • Telecommuting
            • Flexible Schedules
            • Tuition Reimbursement
            • Wellness Program
            • Flexible Spending Accounts
            • Unpaid Time Off
            • Backup CareAt Richard Wolf Medical Instruments Corporation ("RWMIC"), we are committed to maintaining an environment of Equal Opportunity and Affirmative Action.

Keywords: RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, Arlington Heights , Validation Engineer *$1,500 Sign On Bonus*, Engineering , Vernon Hills, Illinois

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