Quality Assurance Scientist- 63617203TT
Our customer is looking for Quality Assurance Scientist.
Review, evaluate and accept complaints to ensure the information is sufficient for a complete investigation.
Verify the initial complaint classification is correct.
Review complaints in accordance with established company procedures and worldwide regulations and standards.
Contact by email or direct phone call external customers, complaint Originators, or Field Service Engineers to obtain all the necessary information to investigate fully.
Exercise judgment within defined procedures and practices to determine appropriate action.
Perform complaint investigation into alleged product non-conformances.
Investigate and follows up on analysis of complaint trend reports.
Escalation of product issues to senior management.
Communicate within a global environment to efficiently obtain the minimal information required from the complaint originator in a timely manner.
Follows through to correct found issues and works with inter-departmental Subject Matter Experts to assist with processing the CF/complaint in a timely manner.
Accountable for customer suggestion/dissatisfaction feedback records. Can work toward performing complaint investigations into alleged product non-conformances as skill set progresses.
Will be able to close complaints to CAPA activities.
Attend and occasionally contributes to technical/risk/department meetings
Bachelor s degree with 0-2 years experience in Technical Field (Science or Engineering) and/or Compliance (Complaints, Quality or Regulatory).
Medical Technology/clinical laboratory background preferred. Excellent writing and organizational skills.
Good computer skills to include Outlook email and other Microsoft applications such as Word, Excel and Power Point. Knowledge of Oracle database application desired. Heavy multi-tasking and organizational skills required.
Work may be independent/flexible, so an ability to manage time and productivity to meet department metrics and a high level of personal integrity is required.
Experience in Complaint Investigation or Post Market Surveillance/QA preferred.
Equal Opportunity Employer
For more information about this position, please contact the Entegee New Hope, MN office at
Please reference job # 63617203TT