Professional - Spec Quality Engineering Compliance

Job Description:

The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate

Key Responsibilities:
Manage customer relationships and expectations during the course of complaint investigation and resolution process
Conduct device analysis in accordance with modelspecific procedures and protocols. Perform root cause analysis to investigate alleged product deficiencies.
Research seek information and input and challenge as appropriate from Product Safety Engineering and other departments/business units for complaint investigations
Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
Summarize findings including a review of the investigation product analysis imaging review instructions for use (IFU) and any other relevant labeling and/or training materials and formulate conclusions
Prepare and submit final customer correspondence
Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g. Manufacturing Quality Assurance Suppliers etc.) to identify assignable root cause resolve open action items and gather additional technical information to resolve complaint
Identify problems and lead projects to improve processes procedures and/or practices; recommend solutions including devising new approaches to problems encountered


Additional Skills:

Experience working in a medical device (cardiovascular endovascular or other critical care/surgical products) healthcare or a related environment required
Proven expertise in MS Office Suite and ability to operate general office machinery
Excellent written and verbal communication skills and interpersonal relationship skills
Demonstrated problemsolving critical thinking and investigative skills
Ability to gain full knowledge and understanding of policies procedures and guidelines relevant to quality compliance
Good knowledge of medical terms and human anatomy
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Ability to manage confidential information with discretion
Attention to detail
Ability to manage competing priorities in a fast paced environment (time management)
Work is performed independently on complex work and reviewed for accuracy and soundness


Education and Experience:
Bachelors Degree or equivalent in related field (scientific field or engineering)
24 years of experience required
Complaint evaluation or NCR investigation experience strongly preferred

Trinus Corporation a leading provider of technology solutions and services with over 25 years of experience is a certified WBE/MBE/SBE/SDB firm accredited by WBENC NMSDC and SBA. Our mission is to shape the future of work by aligning the right mix of people process technology and innovation to efficiently meet our clients business objectives. At Trinus we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit. To learn more about us please visit our website