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 Auditor 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.

About Align Technology

Your growth and well-being:

At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:

- Health and well-being programs to keep you thriving in both body and mind.
- Employee-exclusive discounts on Invisalign products.
- Learning opportunities through online learning resources and support for your individual development plans.
- Inclusive, global workplace that fosters collaboration, recognition and belonging.

Country and/or role specific details will be shared with you by your recruiter during the interview process.





Discover Align:

We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.

Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.

We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive setting that inspires creativity and collaboration.

At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.

As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.

Eager to learn how we embrace our global differences and nurture employee well-being?
Explore Align's culture here!

Want to discover more about exocad and Cubicure? Click on their names for additional information.

Applicant Privacy Policy:

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Equal Opportunity Statement:

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.

📌 QMS ENGINEER (Hyderabad)
🏢 Align Technology
📍 Hyderabad