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Quality Systems and Regulatory Manager
2 months ago
We are seeking a highly skilled Quality Systems and Regulatory Manager to join our team at Tekscan, Inc. This is a critical role that requires a strong understanding of quality management systems, regulatory compliance, and industry standards.
Key Responsibilities- Quality Management System Design and Implementation: Develop and implement quality management systems that meet industry standards and regulatory requirements.
- Regulatory Compliance: Ensure that all products engineered, manufactured, or distributed by Tekscan comply with global regulations for risk, safety, labeling, literature, and clinical protocols.
- Internal Audits and Compliance: Plan and coordinate internal quality audits and ensure that internal audit findings and recommendations are implemented.
- Corrective Actions and Process Improvement: Investigate and drive process improvement by taking a proactive approach to implement preventative actions.
- Reporting and Communication: Report to Tekscan management team on the performance of the Quality Management System based on existing quality objectives.
- Quality Procedures and Standards: Define and establish quality procedures, standards, and specifications.
- Supplier Quality Management: Work with Purchasing to establish and monitor quality requirements from external suppliers.
- Documentation and Change Control: Manage documentation of change control workflow with Engineering and Operations teams.
- Regulatory Developments and Compliance: Monitor Regulatory developments in FDA, Federal Register, International Committees, and other Regulatory guidance documents and assess impact on new and marketed products.
- Education: Bachelor's Degree in Quality Management, Engineering, Business Administration, or equivalent.
- Experience: Minimum 5 years experience as a Quality Manager managing ISO 13485 or other regulated quality management system.
- Skills: Continuous improvement mindset, detail-oriented, excellent written and oral communication skills in English, proficiency using Microsoft 365 tools, ideally with Sharepoint and MS Teams experience.
Tekscan, Inc. is an Equal Opportunity Employer committed to workforce diversity. We offer a competitive salary and benefits package to the successful candidate.
