Bachelor's degree in engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required.
5+ years of experience in quality engineering, product development, or R&D;, preferably in an FDA-regulated industry.
Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
Familiarity with internal and external audits, including Notified Body and FDA inspections.
Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP.
Familiarity with root cause analysis tools, risk management principles, and compliance frameworks.
Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues.
Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations.
Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained.
Proficiency in developing or improving testing methods for complaint investigations and technical activities.
Experience collaborating with cross-functional teams, including Operations, R&D;, and Engineering, to drive product and process improvements.
