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Quality Systems Analyst
hace 2 meses
The Quality Systems Analyst / Quality Systems Lead is the Quality Systems Representative for this location. This role is responsible for ensuring that all quality-related activities are being performed according to the QMS procedures and must have a working knowledge of Quality Assurance and Quality Control.
Key Responsibilities:- Quality Systems Leadership: Provide strategic guidance and oversight to ensure the effectiveness of the Quality Management System (QMS) in accordance with ISO 13485 standards and applicable regulatory requirements.
- Process Improvement: Collaborate with cross-functional teams to identify and implement process improvements, ensuring compliance with regulatory requirements and industry best practices.
- Supplier Management: Evaluate and manage suppliers to ensure they meet the required quality standards, including conducting supplier audits and assessments.
- Document Control: Maintain accurate and up-to-date records, ensuring the most current revisions are available while segregating and storing previous revisions.
- Internal Audits: Participate in the Internal Audit program, ensuring the QMS is functioning as intended and identifying areas for improvement.
- External Audits: Represent the company during external audits, ensuring compliance with regulatory requirements and industry standards.
- Quality Culture: Promote a culture of quality throughout the organization, encouraging a proactive approach to quality management and continuous improvement.
- Collaboration: Work collaboratively across site functions and with all levels of the organization to achieve quality objectives.
- Education: Bachelor's Degree in a related field (Master's Degree preferred).
- Experience: Minimum 5 years of related work experience, with a strong background in quality management and regulatory compliance.
- Skills: Strong analytical skills, excellent communication skills, and the ability to work effectively in a team environment.
- Knowledge: Current working knowledge of ISO 13485 Quality Management Systems and FDA 21 CFR 820, with a strong understanding of quality assurance and quality control principles.
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