Position Overview: The Senior Quality Engineer will play a critical role in ensuring that our medical devices meet the highest standards of quality and regulatory compliance. This role involves leading quality initiatives, managing complex projects, and providing strategic guidance to enhance product quality and reliability throughout the product lifecycle.
Key Responsibilities:
Quality Assurance and Compliance:
- Develop, implement, and maintain quality systems and procedures to ensure compliance with FDA, ISO 13485, and other relevant regulations and standards.
- Conduct internal and external audits, and manage audit responses and CAPAs (Corrective and Preventive Actions).
- Review and approve design and process changes, ensuring they meet quality requirements and regulatory standards.
Risk Management:
- Lead risk management activities including risk assessments, FMEA (Failure Modes and Effects Analysis), and mitigation strategies.
- Analyze quality data to identify trends, root causes, and areas for improvement.
- Develop and implement risk management strategies to ensure device safety and efficacy
Product Lifecycle Management:
- Oversee and support product development processes from design through manufacturing, including validation and verification activities.
- Collaborate with cross-functional teams to resolve quality issues and implement improvements.
- Ensure that design controls, process validations, and other quality requirements are effectively applied throughout the product lifecycle.
Documentation and Reporting:
- Prepare and review quality documentation, including validation reports, technical files, and regulatory submissions.
- Generate and present quality metrics and performance reports to senior management and regulatory bodies.
- Ensure proper documentation practices and data integrity in compliance with regulatory requirements.
Team Leadership and Development:
- Mentor and guide junior quality engineers and other team members.
- Lead or participate in continuous improvement initiatives and quality projects.
- Foster a culture of quality within the organization and promote best practices.
Qualifications:
- Bachelor’s degree in Engineering, Biomedical Engineering, Quality Assurance, or a related field. A Master’s degree or advanced certification (e.g., CQE, CQA) is a plus.
- Minimum of 5 years of experience in quality engineering within the medical device industry, with a strong background in Class II or Class III devices.
- In-depth knowledge of FDA regulations, ISO 13485, and other relevant international standards.
- Proven experience with risk management techniques, including FMEA, and product lifecycle management.
- Strong analytical skills, with the ability to interpret complex data and drive actionable improvements.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and regulatory agencies.
- Demonstrated leadership capabilities and a proactive approach to problem-solving and project management.