Quality Engineer – QMS & Compliance

• Conduct and manage internal audits in accordance with ISO 9001 / ISO 13485 / FDA QSR standards.
• Oversee and track Corrective and Preventive Actions (CAPA) to ensure timely resolution and compliance.
• Manage deviations and non-conformances, from root cause analysis to closure and documentation.
• Update and maintain QMS documents, including SOPs, Work Instructions, and Quality Plans.
• Collaborate with cross-functional teams to handle and resolve production stoppages due to quality issues.
• Prepare for and support regulatory inspections and customer audits.
• Ensure all quality-related activities align with corporate and regulatory requirements.

Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 3–6 years of relevant experience in quality engineering, preferably in a regulated industry (medical devices, pharma, manufacturing, etc.).
• Strong understanding of QMS principles, CAPA systems, audit protocols, and deviation control.
• Hands-on experience with document control tools and electronic QMS systems.
• Excellent problem-solving skills and ability to work under pressure.
• Strong written and verbal communication skills.
• Valid Business Visa (B1/B2 or equivalent) for travel to the US is mandatory.

Preferred Qualifications: Good to have..

• Certification in Lead/Internal Auditor (ISO 9001/13485).
• Experience in FDA/EMEA regulated environments.

Note: The candidate must hold a valid Business Visa (B1/B2 or equivalent) to support short-term travel to the United States as required