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Urgent Requirement for QMS Manager
Job Locaiton: Bothell WA
Job Type: Fulltime / Contract (Either)
As a Medical Device QMS (Quality Management System) Manager, your roles and responsibilities may include:
1. Developing and maintaining the Medical Device QMS: You will be responsible for creating, implementing, and managing the quality management system for medical devices in compliance with relevant regulations and standards. This involves designing processes, procedures, and documentation to ensure quality and regulatory compliance.
2. Regulatory Compliance: You will stay updated with applicable regulatory requirements, such as FDA (Food and Drug Administration) regulations, ISO 13485 standards, and other relevant guidelines. You'll ensure that the medical device QMS is in line with these requirements and coordinate regulatory submissions and audits.
3. Process Improvement: Continuously monitor and evaluate the effectiveness of the QMS processes. Identify areas for improvement and implement corrective and preventive actions to enhance efficiency, reduce errors, and mitigate risks. This involves conducting internal audits, root cause analyses, and implementing process enhancements.
4. Training and Education: Conduct training programs to educate employees on the medical device QMS, relevant regulations, and quality best practices. Ensure that all personnel involved in the QMS are adequately trained and aware of their responsibilities.
5. Document Control: Oversee the document control system to ensure that all documents related to the QMS, including policies, procedures, work instructions, and records, are properly created, maintained, updated, and controlled.
6. Risk Management: Collaborate with cross-functional teams to identify and assess risks associated with medical devices and their manufacturing processes. Implement risk management strategies, such as FMEA (Failure Mode and Effects Analysis), to mitigate risks and ensure patient safety.
7. Supplier Management: Establish and maintain a robust supplier evaluation and qualification process. Ensure that suppliers are compliant with quality requirements, and conduct regular audits and performance assessments to monitor supplier performance.
8. Non-conformance Management: Develop and oversee a process for handling non-conformities, deviations, and complaints related to the medical devices. Investigate root causes, implement corrective and preventive actions, and monitor their effectiveness.
9. Continuous Improvement: Drive a culture of continuous improvement within the organization by promoting quality awareness, facilitating quality improvement initiatives, and benchmarking against industry standards and best practices.
10. External Audits and Inspections: Prepare the organization for external audits and inspections by regulatory bodies and certification agencies. Coordinate and support the audit process, address audit findings, and ensure compliance with regulatory requirements.
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