Medical Device Quality Lead
2 days ago
Job Summary:
We are seeking a Quality and Regulatory Engineer to join our team at Quality Enterprises USA. The successful candidate will have a strong understanding of regulatory requirements and industry standards, as well as excellent problem-solving and analytical skills.
Responsibilities:
- Develop and implement effective CAPA management systems
- Conduct root cause analysis and identify corrective actions
- Ensure adherence to FDA and ISO regulations
Requirements:
- Bachelor's degree in Engineering (Biomedical, Mechanical, Industrial), Quality Assurance, or related field
- Minimum [X] years of experience in quality engineering within medical device or pharmaceutical manufacturing industry
- Familiarity with statistical analysis tools and software (e.g., Minitab)
Salary Range:
$80,000 - $110,000 per year, depending on experience.
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