Quality Assurance Engineering Manager
1 month ago
CathX Medical is seeking an experienced Quality Assurance Engineer to lead the design assurance team in ensuring high-quality medical products. This role involves designing and implementing quality control processes, collaborating with cross-functional teams, and maintaining compliance with regulatory standards.
About CathX Medical:CathX Medical is a leading developer of innovative medical devices. Our team is committed to delivering exceptional products that meet the highest standards of quality and safety.
Key Responsibilities:- Lead the design assurance team in developing and implementing quality control processes
- Collaborate with cross-functional teams to ensure product quality and compliance with regulatory standards
- Analyze data to identify trends and areas for improvement
- Develop and implement corrective actions to address quality issues
- Maintain documentation and records related to quality control processes
- Bachelor's degree in Science, Engineering, or Manufacturing
- At least 5 years of experience in quality engineering or a related field
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
- Excellent communication and interpersonal skills
- Ability to travel as necessary
$120,000 - $150,000 per year
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