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Key Job Responsibilities
Summary: Under the supervision of the onsite engineers conduct investigations of suspected non-conforming devices and materials coming from patient and/or clinical reports of failure. Documents the results of investigations within the complaint handling tool. Provides feedback concerning reoccurring issues and escalates complaints when severity has exceeded the documented expected severity of the Risk Management file (RMM). General housekeeping and movement of devices back to the field via the inventory management system. Cleaning and disinfection of incoming suspected non-conforming material in which has an associated complaint.
Job Responsibilities: Aids in the management of a dedicated departmental support process which has a direct impact on the company's med-tech products by collaborating with different stakeholders to ensure smooth operations, demonstrating great inter-personal and communication skills. Supports the day-to-day activities of a dedicated department, typically involving hands-on, operational tasks essential for providing technical complaint investigation support to meet dynamic environment and continuous improvement goals, exercising autonomy within established procedures. Participates in team meetings, contributing innovative ideas and strategic input, while also capturing detailed minutes that accurately reflect discussions, decisions, and action items, ensuring effective communication and follow-up within the team. Assists in preparation and presentation of reports or findings for internal and external stakeholders as required by manager/supervisor, ensuring that all findings are presented with utmost accuracy and clarity. Maintains up to date knowledge of industry trends, developments, and best practices and learns technical skills related to industry, exhibiting a commercial and growth mindset.
Minimum required Education: High School Diploma plus two years of experience, College or Vocational Education a plus.
Minimum required Experience: Two years of experience in a regulated environment.
Preferred Skills: Stakeholder Management Business Acumen Document Management Root Cause Analysis (RCA) Research & Analysis Documentation & Reporting Microsoft Office Technical Acumen
Benefits:
Paid sick leave, Medical/Dental (optional), 401 (k) Retirement Plan (optional), Employer Paid Life Insurance, Employer Paid Short Term Disability, Optional Life Insurance.
ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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