Quality Assurance Engineer

Job Title: Quality Assurance Engineer/Specialist or Sr Quality Assurance Engineer/Specialist Company: Evolortho Tech Private Limited Location: Hi-Tech Defence and Aerospace Park, Bengaluru (Near Bangalore International Airport) Report to: QARA Department About Evolortho Tech Evolortho Tech Private Limited located in Bengaluru, India and is involving in manufacture of orthopedic and prosthetic medical devices. Evolortho Tech is establishing green filed manufacturing plant and vision to establish a world-class, sustainable manufacturing facility in India for orthopedic implantable medical devices, ensuring global quality standards, surgeon collaboration, and exceptional customer experience. Job Summary This position is part of the quality/regulatory organization and will be based out in Bengaluru, India. Our mission is to ensure that performed quality assurance activities are done by focusing on the quality of the product, the internal and external customer needs, and according to the Quality compliance, India MDR and ISO 13485 standards. This position supports Operations activities such as establishment of QMS, software validation, new document creation, internal/external audit and QMS documentation as related to batch record compliance and ensuring accuracy and traceability of data. Key Responsibilities Support for green filed manufacturing plant establishment for orthopaedic and prosthetic medical devices (QA, QMS, Audit, Validation, Documentation/records) Responsible for the preparation of QMS documentation and updates the quality system as per ISO 13485. Maintain, review, and update QMS documentation (SOPs, Work Instructions, Records) to ensure accuracy and compliance. Lead coordination of internal audits and prepare comprehensive documentation for external audits. Manage supplier documentation and contribute to supplier quality management and risk assessment activities. Ensure robust document control and record retention in compliance with ISO 13485. Promote and implement awareness of quality/regulatory procedures across departments. Ensure that opportunities for continuous improvement are identified by ensuring that systems such as Corrective Action and Change Control Procedures are maintained, notified, implemented and satisfactorily closed out in accordance with written procedures. Ensure that all necessary quality records have been completed and reviewed/approved by responsible personnel. Support and sometimes training sessions, maintaining and updating training records. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. Education Qualifications 5+ years of proven experience as a quality assurance professional in a orthopaedic medical device / Healthcare domain. Specialist in quality process processes with experience in one or more of the following areas: QMS, Risk Management, validation, Audit. QA experience from the medical device industry or other similar regulated industries. In-depth knowledge of relevant standards and regulations in ISO 13485 and MDR). Must have knowledge and experience in working with ISO 14971. Education and Certifications Ø Bachelor s in Mechanical, Engineering, or related field. Ø Master’s degree in life science biochemistry, Microbiology, biotechnology or related field. Ø ISO 13485 Certifications in audit management or regulatory requirements Skills Ø Solid understanding of QMS principles and ISO standards. Ø Excellent attention to detail and ability to maintain documentation accuracy. Ø Strong organizational, analytical, and communication skills. Ø Proficient in Microsoft Office (Word, Excel, Outlook). Ø Ability to work independently, take ownership of tasks, and collaborate effectively within a team. Ø Analytical mindset with attention to detail and strong problem-solving abilities. Ø Excellent measurement planning, data analysis, and interpretation skills. Ø Good communication and documentation skills; ability to translate technical results for non-specialists. Project management and cross-functional collaboration capabilities. Experience Ø 5+ years of experience in a quality or manufacturing environment (preferred). Ø Strong knowledge of ISO 13485 and medical device regulations is an advantage.