Quality Assurance Engineer

Align Technology, Inc.; Telangana; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Align Technology, Inc. in Hyderabad is seeking a Quality Assurance Engineer to join the QARA team. This mid-level role supports manufacturing operations, drives quality assurance activities, CAPA, audits, and regulatory compliance to uphold 21 CFR, ISO 13485 and MDR standards.

You will partner with manufacturing and cross-functional teams to implement process improvements, risk assessments, and documentation controls, while mentoring process owners and maintaining EDMS records.

Qualifications

• Bachelor’s degree in chemistry, engineering, quality or related discipline.
• Minimum 3+ years in quality/compliance in medical devices or regulated industries.
• Strong understanding of Quality System regulations (21 CFR, ISO 13485, MDR 2017/745, GMP).

Responsibilities

• Support manufacturing quality and environmental compliance across dedicated areas.
• Act as local quality partner for PFMEA, non-conformances, CAPAs, and safety requirements.
• Define quality and validation requirements for process changes and drive implementation.
• Interpret and apply regulatory requirements, quality standards and industry regulations.
• Lead continuous improvement initiatives focused on process and product quality.

Skills

Problem solving

Production processes

Validation methods

Statistical analysis

Minitab

SPC

ISO 13485

MS Office

MS Project

Education

Bachelor’s degree in chemistry, engineering or quality

Tools

Minitab

MS Project

Job description

Quality Assurance Engineer

Department: Operations

Employment Type: Full Time

Location: APAC-India-IT Delivery Center Hyderabad

Description

This position is ideal for mid-level quality professionals to join the QARA team as a Quality AssuranceEngineer, supporting manufacturing operations and ensuring compliance with quality managementrequirements. 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 initiativesacross the organization.

Key Responsibilities

• 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).

Skills, Knowledge & Expertise

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.