Website B Braun Medical

Position Summary:


Responsibilities: Essential Duties

Participate in the development and directions of company’s Quality Compliance System to ensure manufacture of products that meet the necessary quality standrads ensuring the quality system’scontinued compliance with all applicable regulatory requirements.
Oversee the company risk management program (Annual Reports); provide risk assessment on product nonconformance and field performance issues. Support the company audit program (internal, suppler, customer, and regulatory) to ensure timely and effective corrections to maintain compliance with FDA cGMPs and Quality System Regulations and ISO standards.
Support the company supplier management program (ASL, Supplier Quality Agreements) to ensure accurate and compliant supplier file content.
Support the company cGMP knowledge management program with HR and Training Department to ensure cGMP proficiency and competency for each worker category. Interface with Manufacturing, Regulatory Affairs, Research & Development, Engineering and other technical disciplines to represent Compliance in project teams, with the objective to assure that project quality compliance objectives are met.
Provide technical recommendation for Management and high level technical personnel regarding product cGMP compliance for projects and/or strategic activities. Provide / formulate recommendations for product disposition or other actions related to product nonconformance and field performance issues.
Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures. Development, implementation and establish dashboards, accountability boards and metrics to measure quality function performance.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Additional responsibilities and experience needed:
Create and approve site corporate audit schedule
Lead Auditor
Oversee audit preparation and hosting
Evaluate/approve audit responses
Ensure audit readiness manage QSRO site
QA approval of complaint investigations
Evaluate changes to corporate QMS and regulations for site