Supports manufacturing quality assurance and regulatory compliance for medical devices. Responsibilities include CAPA and complaint handling, audits, risk assessments, process validation, continuous improvement, document and change control, quality investigations, supplier oversight, and EDMS administration. The role partners with manufacturing and cross-functional teams to maintain quality systems and ensure compliance with ISO 13485, 21 CFR, MDR, and GMP requirements.
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.
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).
• 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.
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.
About
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 environment 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.
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