Baxter is looking to establish and maintain a robust Quality Management System (QMS) to ensure compliance with regulatory requirements and maintain the quality, safety, and effectiveness of their medical products.
Requirements
- Extensive knowledge of relevant FDA, Health Canada and other international regulatory QMS requirements.
- Demonstrated knowledge of current regulatory interpretations of QMS requirements and current industry best practices.
- Proficient in computer system use, including but not limited to Microsoft Office Suite and QMS software.
- Ensures compliance with all applicable regulatory and corporate QMS requirements.
- Ensures the proper review and approval of all new and revised QMS documents prior to issuance including periodic review of documents for adequacy or necessary updates.
- Establishes and maintains appropriate metrics and measures, including for document control, records management, change control, and ensures data analyses is in accordance with applicable procedures to identify issues and trends to initiate and execute corrective and preventive action where indicated.
- Ensures the efficiency, effectiveness and compliance of the document change control process, and that change control records/files are clear, concise and complete, and include documented premarket regulatory impact assessments where indicated.
Responsibilities
- The primary responsibility of this role is the establishment and maintenance of the Baxter-Medina QMS to ensure compliance with all applicable QMS requirements, including 21 CFR Part 820 and related FDA requirements, ISO 13485:2016 and related regulations and standards, other relevant international requirements, as well as Baxter corporate QMS requirements.
- The appropriate organizational structure, resources, responsibilities and processes, policies, procedures, documents and records have been established and are maintained to meet the QMS requirements.
- The QMS is suitable for all operations including, manufacture, packaging, labeling, storage, and distribution; and
- The QMS is effective in maintaining the quality, safety and effectiveness of Baxter-Medina products.
- This role is responsible to establish and maintain an effective document control system, and to ensure all documents required under the QMS are established and maintained appropriately.
- This role is also responsible to establish and maintain an effective records management system, and to ensure all records required under the QMS are maintained appropriately.
- This role is responsible to establish and maintain an effective personnel training system to ensure training requirements are established and maintained and training is conducted and documented in a timely and effective manner.
Other
- Manage a team of quality assurance professionals, providing guidance, mentorship, and support to drive continuous improvement.
- Communicate effectively with senior leadership and stakeholders, providing regular updates on quality assurance activities, milestones, and achievements.
- Drive a culture of quality and innovation, fostering collaboration, creativity, and accountability across the organization.
- BS degree in science or engineering.
- Minimum of 5-8 years of experience in Quality, Manufacturing, Engineering or related field in the medical products industry, which should include 1-2 years of supervisory experience.
