Senior Quality Assurance Professional
We are seeking a seasoned Quality Assurance Specialist to assume key responsibility for ensuring product and process quality in compliance with global regulatory standards.
Key Responsibilities:
* Support new product development and existing manufacturing operations, driving excellence through quality.
* Lead investigations into non-conformances, CAPAs, and complaints, identifying root causes and implementing corrective actions.
* Ensure seamless adherence to ISO 13485, FDA 21 CFR Part 820, and MDR regulations.
* Collaborate with cross-functional teams on design controls, risk management, and validation processes.
* Participate in internal and external audits, fostering a culture of continuous improvement.
* Mentor junior team members and manage supplier quality, promoting best practices throughout the organization.
Qualifications:
* Degree in Engineering, Science, or a related field.
* At least 5 years of experience in quality assurance within a medical device or regulated industry.
* Strong knowledge of regulatory standards, CAPA processes, and validation methodologies.
* Experience with Lean/Six Sigma tools; certification as a CQE or Green Belt is advantageous.
* Excellent problem-solving and communication skills, with the ability to work effectively in a fast-paced environment.
This role demands a highly motivated individual who can collaborate with cross-functional teams to drive quality objectives and contribute to the success of our organization.