Title: Quality Engineer
Duration:6+months with possible extension
• Evaluate, investigate, track and complete complaints through effective and established complaint handling processes.
• 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.
• 3+ 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.