Quality Assurance Engineer
Posted Updated 27
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Summary
Mid-level Quality Assurance Engineer joining Align Technology's QARA team in Hyderabad to support medical device manufacturing — driving CAPAs, complaint handling, audits, document/EDMS control, and process validation to meet ISO 13485, 21 CFR, MDR, and GMP quality standards. Requires 3+ years in quality/compliance in regulated industries.
This position is ideal for mid-level quality professionals to join the QARA team as a Quality Assurance Engineer, supporting manufacturing operations and ensuring compliance with quality management requirements. Partnering with manufacturing, cross-functional, and site stakeholders, you’ll drive quality
assurance activities, process improvements, complaint handling, CAPA management, audits, and regulatory compliance. This role plays a critical part in maintaining product quality, process effectiveness, and adherence to medical device quality standards while supporting continuous improvement initiatives across the organization.
assurance activities, process improvements, complaint handling, CAPA management, audits, and regulatory compliance. This role plays a critical part in maintaining product quality, process effectiveness, and adherence to medical device quality standards while supporting continuous improvement initiatives across the organization.
• Support manufacturing business functions in product quality and environmental compliance across dedicated operational areas.
• Act as a local quality partner for discussions related to PFMEA, non-conformances, CAPAs, product quality, and safety requirements.
• Define quality and validation requirements associated with process changes and collaborate with local teams on implementation.
• Interpret and apply applicable regulatory requirements, quality standards, and industry regulations.
• Identify, analyze, and lead continuous improvement initiatives focused on process and product quality enhancement.
• Support internal and cross-functional teams in quality improvement and operational excellence activities.
• Ensure quality documentation is established, maintained, effective, and continuously improved.
• Coordinate complaint handling, root cause investigations, and corrective and preventive action (CAPA) activities.
• Participate in risk assessments related to processes, products, and design activities.
• Support regulatory, corporate, and external audits and inspections related to the Quality Management System.
• Conduct internal and supplier audits to verify compliance with quality requirements and standards.
• Ensure appropriate quality controls are implemented and maintained throughout manufacturing processes.
• Serve as a subject matter expert for quality processes, providing guidance and coaching to process owners and stakeholders.
• Maintain site document control and change control processes, ensuring compliance with local regulations and internal procedures.
• Review quality documentation, change controls, document archives, translations, and EDMS records for compliance and accuracy.
• Support administration and maintenance of the electronic document management system (EDMS).
• Act as a local quality partner for discussions related to PFMEA, non-conformances, CAPAs, product quality, and safety requirements.
• Define quality and validation requirements associated with process changes and collaborate with local teams on implementation.
• Interpret and apply applicable regulatory requirements, quality standards, and industry regulations.
• Identify, analyze, and lead continuous improvement initiatives focused on process and product quality enhancement.
• Support internal and cross-functional teams in quality improvement and operational excellence activities.
• Ensure quality documentation is established, maintained, effective, and continuously improved.
• Coordinate complaint handling, root cause investigations, and corrective and preventive action (CAPA) activities.
• Participate in risk assessments related to processes, products, and design activities.
• Support regulatory, corporate, and external audits and inspections related to the Quality Management System.
• Conduct internal and supplier audits to verify compliance with quality requirements and standards.
• Ensure appropriate quality controls are implemented and maintained throughout manufacturing processes.
• Serve as a subject matter expert for quality processes, providing guidance and coaching to process owners and stakeholders.
• Maintain site document control and change control processes, ensuring compliance with local regulations and internal procedures.
• Review quality documentation, change controls, document archives, translations, and EDMS records for compliance and accuracy.
• Support administration and maintenance of the electronic document management system (EDMS).
Education: Bachelor’s degree in chemistry, Engineering, Quality, or a related discipline, postgraduate studies in Quality Management are preferred. Experience: Minimum 3+ years of experience in a quality or compliance role within medical devices or other regulated industries. Strong understanding of Quality System regulations including 21 CFR, ISO 13485, MDR 2017/745, and GMP.
Skills: Practical knowledge of problem-solving methodologies, production processes, validation methods, statistical analysis, Minitab, SPC, ISO 13485, and Microsoft Office tools including MS Project.
Communication: Strong written and verbal communication skills with the ability to synthesize and present information effectively. Fluent English communication skills are required.
Teamwork: Ability to collaborate across interdisciplinary teams, build strong relationships, work independently, and perform effectively in a fast-changing environment.
Complementary skills
• Black Belt or Green Belt certification preferred.
• ISO 13485 Internal Auditor certification preferred.
• Goal-oriented mindset with strong interpersonal skills and the ability to manage multiple priorities under pressure.
• Experience with document control systems, change management processes, CAPA, audits, and continuous improvement initiatives.
Skills: Practical knowledge of problem-solving methodologies, production processes, validation methods, statistical analysis, Minitab, SPC, ISO 13485, and Microsoft Office tools including MS Project.
Communication: Strong written and verbal communication skills with the ability to synthesize and present information effectively. Fluent English communication skills are required.
Teamwork: Ability to collaborate across interdisciplinary teams, build strong relationships, work independently, and perform effectively in a fast-changing environment.
Complementary skills
• Black Belt or Green Belt certification preferred.
• ISO 13485 Internal Auditor certification preferred.
• Goal-oriented mindset with strong interpersonal skills and the ability to manage multiple priorities under pressure.
• Experience with document control systems, change management processes, CAPA, audits, and continuous improvement initiatives.
