# Quality Assurance Engineer at Jobs Aligntech > Onsite · India · Unspecified · QA / Test · open. Source: https://alderhq.app/jobs/pinpoint%3Ajobs-aligntech%3A610038 (read 2026-11-07). ## Facts (observed) - Company: [Jobs Aligntech](https://alderhq.app/companies/jobs-aligntech) - Location text: APAC-India-IT Delivery Center Hyderabad - Where it can be done from (inferred): Onsite · India (evidence: "Location lists "hyderabad"") - Posted: already open when tracking began; date unknown - First seen by alder: 2026-11-04 · last verified: 2026-11-04 - Reposted: 0 times · edited: 0 times - Apply on the employer's site: https://jobs.aligntech.com/en/postings/44dc3f0f-5332-4127-aa6a-18725cfaa133 ## Pay and sponsorship - Posted pay: not posted ## Description (the employer's text) 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. ### 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 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. --- Data: alder (https://alderhq.app). Cite https://alderhq.app/jobs/pinpoint%3Ajobs-aligntech%3A610038 and the date you read it. Observed facts come from the employer's own listing; location reach, level, family and skills are inferences.