Job Title: Quality Engineer PM Consultant II
Duration: 6+ months with possible extension
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
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.
Please send me your confirmation that no one else has contacted you for this position apart from APN Team.
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560
Direct: 510.870.8798 | Fax: 510.623.5055 | firstname.lastname@example.org