Responsibilities and Requirements :
- Proficiency in root cause analysis techniques and CAPA management.
- Strong understanding of regulatory requirements (, FDA, ISO) and industry standards.
- Excellent problem-solving, analytical, and communication skills.
- Ability to work independently and as part of a cross-functional team.
- Familiarity with statistical analysis tools and software (, Minitab) is an advantage.
- Bachelor's degree in Engineering (Biomedical, Mechanical, Industrial), Quality Assurance, or a related field.
- Advanced degrees or certifications (, CQE, CQA) are a plus.
- Minimum of [X] years of experience in quality engineering within the medical device or pharmaceutical manufacturing industry.