Quality Compliance Specialist

Our team is looking for a quality compliance specialist with experience working in medical device, healthcare or pharma.

Skills:

Advanced 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
Full knowledge and understanding of procedures, and guidelines relevant to quality compliance
Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Attention to detail
Ability to interact with multiple teams

About the role:

Research, seek information and input, and challenge as appropriate, partnering with other departments/business units for complaint investigations
Identify problems, improve processes, recommend solutions, including devising new approaches to problems encountered
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
Investigate customer complaints, make initial reporting decisions, facilitate investigations, and ensure completeness and consistency of the documentation for complaints
Run weekly meetings to discuss complaint issues with affected functions to identify assignable root cause, resolve open action items, and gather information to resolve complaint
Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics

Education & Experience

Bachelor's Degree or equivalent in related field
0-2 years of experience required

Monday-Friday
Hybrid Schedule