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Quality

4 months ago

Lake Geneva, United States Medix Full time

Position Overview: We are seeking a detail-oriented Quality Specialist to join our team with 1 to 2 years of experience. The primary responsibility of this role is to manage non-conformances, conduct investigations, and compile comprehensive reports for audits. The successful candidate will play a crucial role in maintaining and improving our quality management systems to ensure compliance with industry standards and regulations.

Key Responsibilities:

  1. Non-Conformance Management:
  • Receive, review, and assess non-conformance reports from various sources, including internal departments, suppliers, and customer feedback.
  • Classify non-conformances based on severity, impact on product quality, and potential risks.
  1. Investigations:
  • Conduct thorough investigations into quality-related incidents, deviations, and complaints, utilizing investigative techniques such as root cause analysis, Fishbone diagrams, and 5 Whys.
  • Collect and analyze data, documentation, and relevant information to identify contributing factors and systemic issues.
  1. Report Writing:
  • Prepare detailed investigation reports documenting findings, analysis, conclusions, and recommendations in a clear and concise manner.
  • Ensure that all reports comply with regulatory requirements, internal quality standards, and best practices.
  1. Audit Support:
  • Assist in the preparation for internal and external audits, including compiling documentation, organizing evidence, and facilitating audit activities.
  • Participate in audit processes, addressing auditor inquiries, and providing relevant information and clarification as required.
  1. Continuous Improvement:
  • Proactively identify opportunities for process improvements and efficiency gains within the quality management system.
  • Recommend and implement enhancements to procedures, workflows, and documentation to prevent recurrence of non-conformances and improve overall quality performance.

Qualifications:

  • 1-2 years of experience in non-conformance, investigations and audits in an ISO 13485 environment. Looking for someone that is hard-working and coachable
  • Microsoft Excel (make sure they are good with formulas), Word, Access, Teams
  • Reliable and accountability to show up, be on time, quickly learn in a high work-load and stress environment