Post Market Quality Assurance Specialist
1 week ago
The role of the Post Market Quality Assurance Specialist is essential in managing complaint handling processes to uphold regulatory standards and enhance customer satisfaction. This position is responsible for coordinating and submitting necessary regulatory documentation to the FDA and relevant Country/Regional authorities.
Key Responsibilities- Manage the receipt, documentation, investigation, and resolution of customer complaints to ensure adherence to regulatory standards (e.g., FDA, CMDR, ISO) and maintain customer satisfaction.
- Comply with all Exactech protocols and requirements, evaluating complaint incidents for regulatory reporting obligations.
- Prepare and submit regulatory reports to the FDA or Regional Competent Authorities within the required timelines.
- Identify and escalate high-severity incidents to Management for further action.
- Contribute to the fulfillment of complaint management activities in alignment with departmental metrics and performance indicators.
- Assist in audits and respond to audit inquiries related to complaints.
- Participate in continuous improvement initiatives and special projects as assigned.
- Support the training of team members involved in complaint handling.
- Help in the revision or creation of procedures, work instructions, forms, reports, and templates to standardize departmental operations.
- Understand and apply Exactech's Quality System along with relevant FDA and international standards. Provide assistance to other employees, teams, and sales personnel as needed.
- Associate's Degree from an accredited institution is required; a Bachelor's Degree is preferred.
- A degree in Allied Health, Statistics, Epidemiology, Life Sciences, or Biomedical Engineering is highly preferred.
- A minimum of 1 year of experience in a complaint handling or post-market surveillance role within a Medical Device or Pharmaceutical FDA-regulated environment.
- If lacking prior complaint handling experience, 2 years in a quality assurance role within a Medical Device or Pharmaceutical FDA-regulated environment is acceptable.
- Proficient understanding of FDA, EU, and other global regulations concerning complaint handling and Recalls/FSCA is required.
- Experience with FDA/ISO quality management system regulations is essential.
- Familiarity with quality system management software is highly preferred.
- Proficient in Windows-based office productivity tools.
- Strong analytical skills with a keen attention to detail.
- Excellent organizational and time management capabilities.
- Effective written, verbal, and presentation communication skills.
- Ability to consistently meet high standards of accuracy in documentation, data compilation, and simple analyses.
- Self-motivated; capable of establishing priorities and working independently to meet deadlines.
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