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Quality Assurance Manager
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Rogers Foam Tijuana is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the effectiveness of our quality system and maintaining compliance with regulatory requirements.
Key Responsibilities- Strategic Oversight: Provide leadership direction to ensure the quality system is effective and compliant with regulatory requirements.
- Regulatory Compliance: Ensure compliance with 21 CFR Part 820, ISO13485:2016, ISO9001:2015, and MDR 2017/.
- Quality Program Development: Develop and implement quality programs and process improvement initiatives to ensure compliance with final product quality standards.
- Data Analysis: Acquire and analyze data using standard quantitative and statistical methods to facilitate process analysis.
- Problem Solving: Apply problem-solving and quality improvement tools and techniques to overcome barriers to quality improvements.
- Product Design: Understand product design, design transfers, and production line quality standards.
- Reliability and Maintainability: Demonstrate knowledge of reliability, maintainability, and product risk management.
- Process Validations: Perform process validations (IQ/OQ/PQ), equipment qualification, and test method validations.
- Communication: Strong communication skills, including written and verbal communication.
- Internal Audit: Supervise the internal audit program and ensure compliance with applicable standards.
- Training and Implementation: Lead in training and implementation of regulatory quality systems, Good Manufacturing Practices (GMPs), and Good Documentation Practices (GDPs).
- Education: Bachelor's degree in Engineering or related field, or equivalent work experience.
- Experience: 3+ years as QA Manager or QA Coordinator in a related field within medical device manufacturing.
- Language: Advanced English (read, write, speak).
- Leadership: Solid leadership and mentorship experience.
- Competences and Skills: Proven experience in medical device manufacturing, governmental regulations, and standards; demonstrated knowledge and experience of medical device risk management standards; and strong use of statistics theory and analysis.
