Job Summary

Quality System Specialist

  • Location:
    Vernon Hills , Illinois
  • Category:
    Quality Assurance
  • Contract Type:
    Contract/Temporary
  • Job reference:
    US_EN_3_105989_320011

Quality System Specialist job available in Vernon Hills, IL
10 month contract to hire
***W-2 Candidates only please***


Job Description Summary
As directed by the Quality Manager, the Quality System Specialist is accountable for support of the continued development, improvement and implementation of the Quality Systems.
This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to New Product Development and project teams for process improvement and continuous improvement activities The Designated Complaint Handling Unit (DCHU) represents the customer facing department responsible for managing the customer experience for our products and services and for prioritizing business opportunities and product/service solutions.

The major activities of the incumbent are:

Accountable for setting own work direction and completing work tasks.
Able to manage the end to end process of customer complaints including review and maintenance of complaint files and responses sent to customer.
Escalation of complaints and assist in complaint investigations as required.
Review all customer complaints, investigations and communications for validity and assures compliance with policies and procedures.
Development of Complaint Closure Letters as required.
Work with Regional Complaint Centers to resolve and address complaint handling issues.
Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports.
Responsible for reviewing customer complaints received for Medical Device Reports (MDRs), FDA and ISO requirements.
Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance.
Files MedWatch reports after Leader reviews and approves.
Develop, implement and follow procedures to ensure timely and accurate receipt documentation, analysis, and response to customer complaints.
Contribute to the business-wide Quality strategy and objectives.
Ensure the customer complaint investigation, procedures, and activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting
Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary.
Represent BDMPS on cross-business teams related to Quality Systems.

Requirements

Education/Degree Typically requires a minimum of a Bachelor’s Degree
Certifications
Prefer a minimum 3 years relevant experience or a combination of equivalent education and relevant experience.


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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
EEO is the Law (poster) | EEO is the Law (poster supplement) | Reaffirmation of Affirmative Action Policy Statement