Summary:

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 model-specific 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 problem-solving , 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:

• Bachelor's Degree or equivalent in related field (scientific field or engineering)
• 2-4 years of experience required
• Complaint evaluation or NCR investigation experience strongly preferred

Job Type: Contract

Salary: $40.00 - $43.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Application Question(s):

• Do you have 2 years of working experience with medical device complaint investigations/management (CAPA's, NCR's, and Root-Cause Analysis) and medical device reporting?
• Do you have 2 years of working experience as a Quality Compliance Professional handling complaint evaluations or NCR investigations within a Medical device industry?
• Do you have working experience in medical device (cardiovascular, endovascular, or other critical care/surgical products)?
• Do you have Bachelor's Degree ?

Work Location: In person