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Quality Complaint Associate
Ref No.: 19-13397
Location: Brea, California
Our client, a leading Biomedical Laboratory Instruments company is looking for a Quality Complaint Associate. This is for an initial duration of 3 months and is located in Brea, CA
Description/Comment:
  • Quality Complaint Associate will have direct ownership and administrative responsibility of the US Customer Operations (USCO) training database and training upkeep in accordance with Client policies and procedures. Review, evaluate and accept complaints to ensure the information is sufficient for a complete investigation.
 
Day to Day Requirements:
  • 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
 Job Requirements:
  • Bachelor´s degree with 2+ years' experience in Technical Field (Science or Engineering) and/or Compliance (Complaints, Quality or Regulatory).
  • Medical Technology/clinical laboratory background.
  • Knowledge of Immunoassay or Chemistry product lines.
  • Excellent systems knowledge (instrument hardware as well as reagents) is highly desired.
  • 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.
  • 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
  • SHIFT SCHEDULE: 6:30am - 3:00pm, M-F       

Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com / Neha.T@sunrisesys.com.  Thank You.