Role : Sr Quality Engineer

Duration : 24+ Months

Job Summary:

The Senior Quality Engineer is responsible for ensuring that products meet regulatory and customer quality standards. This includes leading quality initiatives, managing cross-functional teams, resolving complex quality issues, and driving continuous improvement projects.

Key Responsibilities:

• Maintain and improve the Quality Management System (QMS) to comply with ISO 13485, FDA regulations, and other standards.
• Oversee CAPA, process validation, and risk management activities.
• Conduct internal and supplier audits and lead investigations into non-conformances.
• Drive continuous improvement initiatives using Lean or Six Sigma.
• Collaborate with suppliers and ensure compliance with quality standards.
• Provide technical guidance and mentorship to junior engineers.

Qualifications:

• Bachelor's degree in Engineering or related field.
• 5-7 years of experience in quality engineering, preferably in regulated industries.
• Expertise in CAPA, process validation, and FMEA.
• Certifications such as CQE or Six Sigma preferred.

Key Competencies:

• Strong problem-solving and analytical skills.
• Excellent communication and leadership abilities.
• Experience in ISO 13485 and FDA regulations.