Quality Assurance Compliance Specialist

2 days ago


New York, New York, United States Avetix Group Full time

**About the Role**

We are seeking a highly motivated and detail-oriented Quality Compliance Associate to join our team at Avetix Group. As a key member of our organization, you will play a pivotal role in ensuring adherence to industry regulations and corporate policies, maintaining our reputation for excellence in the medical biotech space.

**Key Responsibilities:**

  • Initiate and manage non-conformities, Corrective Actions/Preventive Actions (CAPAs), and change management processes to ensure seamless operations.
  • Oversee distributor and supplier qualifications to guarantee compliance with industry standards.
  • Maintain a Quality Management System (QMS) compliant with FDA, ISO 13485, and MDSAP standards, ensuring our organization remains at the forefront of regulatory requirements.
  • Evaluate QMS performance and support the R&D team in design control records, driving continuous improvement and innovation.
  • Supervise internal audits and manage quality functions across departments to uphold high compliance standards, fostering a culture of excellence.

**Ideal Candidate:**

We are looking for a motivated, detail-oriented individual with a strong background in quality compliance. A proactive mindset, coupled with a commitment to continuous improvement and collaboration, is essential. The ideal candidate will also be adaptable and open to ongoing training to stay current with industry advancements.

**Key Skills and Qualifications:**

  • Education: Bachelor's degree in biology or a closely related discipline.
  • Experience: Minimum of 3 years in the medical device or pharmaceutical industry, with a comprehensive understanding of compliance standards and regulatory requirements. Knowledge of PRP and Tissue Engineering is a plus.
  • Technical Proficiency: Familiarity with Veeva Vault, ISO 13485, MDSAP, and CAPA management processes.
  • Organizational Skills: Ability to manage multiple compliance tasks efficiently, prioritize effectively, and meet deadlines.
  • Communication Skills: Exceptional verbal and written skills for effective collaboration and clear documentation.


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