Description

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

Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations

Identify problems and lead projects to improve processes, procedures, and/or practices; 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

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

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

Full knowledge and understanding of Client policies, procedures, and guidelines relevant to quality compliance

Good knowledge of medical terms and human anatomy

Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations

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 interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Work is performed independently on complex work and reviewed for accuracy and soundness

Education and Experience:

Bachelor's Degree or equivalent in related field

1+ years of experience required

Education: Bachelors Degree