QA Engineer III (Complaints)

Title: QA Engineer III (Complaints) 
Location: Carlsbad CA
Duration:  6+ months
 
DESCRIPTION:
• Evaluate, investigate, track and complete complaints through effective and established complaint handling process.
• Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
• Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings.
• Coordinate with the reportable complaint investigators in providing any missing information for root cause activities.
• Collaborate with Engineering, Customer Support, Field personnel, Market Service Order reviewers and other appropriate groups for adequate initial evaluation of complaints.
• Collaborate with Adverse Event Coordinators for reportable complaints as well as Product Safety Committees for Correction and Removal process.
• Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data gets pushed to the appropriate departments for actions.
• Support reviews and audits assigned.
• Work with the Post Market Surveillance Manager for any other projects assigned.
To succeed in this role, you should have the following skills and experience

REQUIREMENTS:
 • 3-5 years of experience in a medically regulated and technical environment in (FDA Class I or II equivalent – Class III a plus). 
 • Bachelor Degree or higher in scientific, health care, nursing or related field, or relevant years work experience. 
 • Demonstrated strong results orientation. 
 • Proficiency using statistical tools such as Tableau, Minitab, and various other computer software applications. 
 • Proficiency using office tools such as Microsoft Access and Excel, ClearQuest, and various other computer software applications. 
 • Must be able to work under pressure to meet regulatory reporting time frames and company requirements. 
 • Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment. 
 • Requires the proven ability to consistently meet and/or exceed goals. Must be capable of making commitments, setting priorities, and delivering results on time and on budget. Effective team building skills. 
 • Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives. 

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