QA Complaint Coordinator - Mondo

Apply now: QA Complaint Coordinator, Hybrid opportunity local to Bedford, MA. The start date is ASAP for this long-term contract position.

Job Title: QA Complaint Coordinator
Location: Bedford, MA (3 days/week)
Duration: 12+ months with opportunity for hire after 6 months
Rate: Up to $30/hr W-2
Start Date: ASAP

Job Summary:

My client, a leading medical device company, is seeking a dedicated and detail-oriented QA Complaint Coordinator for the postmarket team at a leading medical device company.

As a Quality Assurance Complaint Coordinator, you will play a crucial role in maintaining and managing the documentation processes for our complaint intake processes. Your meticulous attention to detail and expertise in documentation management will contribute to ensuring compliance with regulatory requirements and quality standards. This position offers an opportunity to work in a fast-paced environment and make a significant impact on patient care.

Key Responsibilities:

Document Reviews: Facilitate document reviews by coordinating with subject matter experts, tracking review timelines, and ensuring timely completion of reviews.

Document Distribution and Training: Manage the distribution of controlled documents, maintain records of document access, and support the training process by ensuring employees are trained on the proper use and understanding of quality documents.

Document Archiving and Retrieval: Establish and maintain a robust document archiving system to ensure easy retrieval, traceability, and document retention in accordance with regulatory requirements.

Audit Support: Assist in internal and external audits by providing requested documentation and ensuring all documents are audit-ready.

Adherence to Regulatory Standards: Stay up-to-date with regulatory requirements, industry trends, and best practices related to document control and quality documentation management.

Qualifications:

• Relevant work experience in an administrative capacity, ideally in a medical device company or similar industry
• Understanding of quality management systems, document control processes, and regulatory requirements (e.g., FDA, ISO 13485) is a plus
• Proficiency in document control software and electronic document management systems.
• Excellent organizational skills with exceptional attention to detail.
• Strong written and verbal communication skills.
• Ability to work independently, manage multiple tasks simultaneously, and meet deadlines.
• Collaborative mindset with the ability to work effectively in cross-functional teams.