Qualifications

• Bachelor's or Master's degree in engineering, life sciences, or related discipline.
• 6+ years of quality experience in the medical device industry.
• Deep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP).
• Proven success influencing at senior levels and leading cross-functional projects.
• Advanced statistical analysis and risk management skills, Six Sigma Black Belt preferred.
• Track record of leading audits and remediation efforts.

Responsibilities

• Act as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance.
• Optimize quality system processes including CAPA and supplier quality.
• Lead complex investigations and implement corrective actions.
• Provide expertise in reliability engineering and process validation.
• Represent the company during FDA inspections and audits.
• Collaborate with leadership to align quality strategies with business objectives.
• Mentor and coach quality engineers across multiple sites.

Benefits

• Annual CIP bonus opportunity of up to $10,000.00
• Involvement in cross-functional leadership and strategy alignment
• Opportunities for professional development and certification support
• Potential for international travel to conduct audits and inspections