Sr. Executive or Assistant Manager-QA & RA

Company Description Ace Cathtech Pvt. Ltd., established in April 2024, is a modern manufacturer of premium medical devices specializing in nephrology, cardiac surgery, critical care, and anesthesia products. Based in IMT Sector 68, Faridabad, Haryana, the company operates a state-of-the-art facility designed to serve the evolving needs of the healthcare sector. Production takes place in a Class 7 cleanroom environment aligned with CDSCO guidelines and ISO 13485 standards to ensure product safety and reliability. A dedicated team follows strict SOPs, comprehensive sterilization protocols, and advanced quality measures throughout the manufacturing process. With a strong focus on innovation and patient safety, Ace Cathtech aims to deliver solutions that improve clinical outcomes and customer satisfaction.
Role Description This is a full-time, on-site role based at Ace Cathtech’s facility in Faridabad for a Sr. Executive or Assistant Manager – QA & RA. The role involves overseeing quality assurance processes across the manufacturing lifecycle, including documentation, in-process checks, final product release, and adherence to ISO 13485 and CDSCO regulatory requirements. Responsibilities include managing quality management systems, conducting internal audits, coordinating corrective and preventive actions, and ensuring compliance with sterilization and cleanroom standards. The position also requires handling regulatory affairs activities such as preparation and review of technical documentation, supporting product registrations, and maintaining up-to-date knowledge of relevant regulations and guidelines. The role entails close collaboration with production, R&D, and management teams to drive continuous improvement and support successful regulatory inspections.
Qualifications
Candidates should possess strong executive administrative assistance and general administrative assistance skills to manage documentation, records, and quality system files.
Candidates should possess experience in executive support and handling expense reports for QA & RA-related activities, audits, and regulatory submissions.
Candidates should possess excellent communication skills to coordinate with internal teams, regulatory bodies, and external auditors.
Relevant qualifications such as a bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related discipline; advanced certifications in Quality Assurance or Regulatory Affairs are an advantage.
Knowledge of ISO 13485, GMP, and CDSCO requirements, along with experience in medical device manufacturing and cleanroom environments, is highly beneficial.
Proficiency in documentation control, internal auditing, CAPA management, and use of quality and regulatory software tools is preferred.
Strong analytical skills, attention to detail, and the ability to work collaboratively in a fast-paced, compliance-driven environment.

Work arrangement
No