QMS ENGINEER

Align Technology, Inc.; Hyderabad; On-site; INR 1,708,000 - 2,221,000; Full time

Job summary

Align Technology, Inc. is seeking a QMS Engineer to join the QARA team in Hyderabad, APAC-India IT Delivery Center. You will support manufacturing operations, drive quality improvements, manage CAPA, audits, complaint handling, risk assessments, and document control processes.

The role focuses on regulatory compliance, process quality, and continuous improvement across the organization. Bachelor’s degree in a related field and 3+ years in quality/compliance within regulated industries are

Qualifications

• Bachelor's degree in Chemistry, Engineering or Quality required.
• Minimum 3+ years in quality/compliance in medical devices or regulated industries.
• Strong knowledge of 21 CFR, ISO 13485, MDR 2017/745, GMP.
• Fluent English communication skills.

Responsibilities

• Identify, analyze, and lead continuous improvement initiatives to enhance process and product quality.
• Support cross-functional teams in quality improvement and process optimization activities.
• Ensure quality documentation is established, maintained, and compliant with regulatory requirements.
• Coordinate complaint handling activities and lead root cause investigations for quality issues.
• Work with cross-functional stakeholders to investigate non-conformances and implement corrective actions; monitor CAPA effectiveness.
• Conduct risk assessments related to products and processes.
• Support inspections by internal/external agencies related to QMS.
• Conduct internal and supplier audits to ensure QMS compliance.
• Maintain quality controls within manufacturing processes.

Skills

Quality management

CAPA

Root cause analysis

Audits

Quality improvement

Education

Bachelor’s degree in Chemistry, Engineering, Quality

Postgraduate in Quality Management

Tools

Minitab

MS Project

Office suite

Job description

QMS ENGINEER

Department: Operations

Employment Type: Full Time

Location: APAC-India-IT Delivery Center Hyderabad

Compensation: Rs1,708,329 - Rs2,220,828 / year

Description

This position is ideal for quality and compliance professionals to join the QARA team as a QMS Engineer, supporting manufacturing operations and ensuring the effectiveness of the Quality Management System. Partnering with manufacturing and cross-functional teams, you’ll drive quality improvement initiatives, CAPA management, audits, complaint handling, risk assessments, and document control processes. This role is critical in maintaining regulatory compliance, enhancing process quality, and supporting continuous improvement across the organization.

Key Responsibilities

• Identify, analyze, and lead continuous improvement initiatives focused on enhancing process and product quality and exceeding customer expectations.
• Support internal and cross-functional teams in quality improvement and process optimization activities.
• Ensure quality documentation is established, maintained, implemented, and continuously improved to meet business and regulatory requirements.
• Coordinate complaint handling activities and lead root cause investigations for quality-related issues.
• Work with cross-functional stakeholders to investigate non-conformances, implement corrective actions, and monitor CAPA effectiveness.
• Conduct and participate in risk assessments related to products, processes, and designs.
• Support corporate and external agency inspections related to the Quality Management System.
• Conduct and participate in internal and supplier audits to ensure Quality Management System compliance.
• Ensure appropriate quality controls are implemented and maintained within manufacturing processes.
• Serve as a subject matter expert for quality systems and quality process improvement projects.
• Guide, coach, and support process owners and stakeholders on quality-related requirements and best practices.
• Ensure timely achievement of assigned quality objectives, deliverables, and project deadlines.
• Maintain site document control procedures in compliance with regulatory requirements and internal policies.
• Manage site change control activities within the EDMS, including review of change control documentation and deliverables.
• Review documentation, document archives, procedures, translations, and change control records to ensure accuracy and compliance.
• Support administration and maintenance of the electronic document management system (EDMS).
• Create and maintain active and archival documentation records for controlled documents.

Skills, Knowledge & Expertise

Education: Bachelor’s degree in Chemistry, Engineering, Quality, or a related field required; postgraduate studies in Quality Management preferred.
Experience: Minimum 3+ years of experience in a quality or compliance role within medical devices or other regulated industries. Solid understanding of Quality System regulations including 21 CFR, ISO 13485, MDR 2017/745, and GMP.
Skills: Practical knowledge of quality problem‑solving tools, production processes, validation methods, statistics, Minitab, SPC, ISO 13485, and Microsoft Office applications including MS Project.
Communication: Strong written and verbal communication skills with the ability to effectively synthesize and present information. Fluent English communication skills required.
Teamwork: Ability to collaborate effectively with cross-functional teams, build strong working relationships, work independently, and perform successfully in a fast-paced environment.

Complementary skills

• Black Belt or Green Belt certification preferred.
• ISO 13485 Internal Audit certification preferred.
• Experience with CAPA, complaint handling, risk management audits, document control, and quality system compliance activities.
• Strong interpersonal, organizational, and project follow-through skills with the ability to work under pressure and adapt to changing priorities.