Job Description

The Quality Compliance Specialist is responsible for investigating customer complaints, makes initial reporting decisions, facilitates investigations, prepares medical device reports, generates customer letters, and ensures completeness and consistency of the documentation for complaints. Reporting Relationships: This job reports to: Quality Compliance Supervisor. Reporting directly (or indirectly) to this position are the following job titles: Not Applicable.

DUTIES & RESPONSIBILITIES: INVESTIGATE COMPLAINTS DAILY:

• Perform preliminary classification of complaints and elevate complaints that require additional review for reporting (e.g. Medical Device Reporting, Medical Device Vigilance or other event reporting for International bodies worldwide). Ensure all potentially reportable complaints are escalated to appropriate levels of management;
• Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close complaint;
• Escalate complaints when new failure modes are encountered and work with OEM, Engineering, Field Personnel, and Quality Assurance to investigate;
• Participate in the investigation and review process related to post-market adverse event reporting for the US, Europe, and other International regulatory bodies;
• Ensure all required medical device reports are submitted in accordance with Company procedures;
• Collaborate with clinical staff on hazards evaluation and potential patient risk and safety hazards investigations, as assigned;
• Monitor trends related to complaints and escalate issues to management;
• Perform initial evaluation of complaints for reporting in accordance with regulations and Company procedures;
• Provide ancillary support in representing the complaint handling process during internal and external audits;
• Provide training to internal team members (i.e. customer interfacing teams) regarding the Company’s complaint handling process and requirements;
• Interface with customers, hospital risk management personnel to procure information relate to complaint handling, as requested;
• Drafts and reviews customer responses and or responses to regulatory bodies;
• Ensure that all complaints requiring customer responses are properly addressed, as assigned;
• Perform other duties or special projects as assigned.

Minimum & Preferred Qualifications and Experience:

MINIMUM QUALIFICATIONS:

• Two to three years of experience processing complaints in medical device industry;
• Prior experience with MedWatch, familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);
• Familiarity with medical device complaint files and quality records;
• Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;

SKILLS REQUIRED:

• Strong computer skills
• Ability to interact effectively on a team and with internal and external customers
• Demonstrated written and verbal communication skills
• Demonstrated independent worker with ability to focus
• Demonstrated attention to detail Preferred Qualifications:
• Clinical experience/background is preferred

EDUCATION:

• High School Diploma or GED is required.
• Bachelor’s degree in Engineering, Life Science, or equivalent experience and education is preferred.

Bachelor’s degree in Sciences or Clinical Background is highly desirable