DQA || 6 to 15 Years || Pune || Gurugram

We are seeking a highly skilled and experienced professional for the role of Design Quality Assurance (DQA) in Pune. The ideal candidate will have a strong background in quality management systems, regulatory compliance for medical devices, and hands-on experience with statistical tools and project management. This role is critical in ensuring product quality and regulatory adherence for Class II and III medical devices.

Key Responsibilities:

• Ensure compliance with ISO 13485 , ISO 14971 , and other relevant quality standards.
• Oversee design assurance, design control, verification, and validation activities.
• Support regulatory submissions and audits for Class II and III medical devices.
• Utilize statistical tools (e.g., MINITAB) for data analysis and quality improvement.
• Apply Geometric Dimensioning and Tolerancing (GD&T) in product design and evaluation.
• Manage projects using tools like MS Project and ensure timely delivery.
• Collaborate with cross-functional teams to drive quality initiatives.

Primary Skills (Mandatory):

• Professional training/certification in Quality Management Systems (ISO 13485, ISO 14971).
• Strong understanding of medical device regulatory requirements .
• Experience with design assurance/control , verification , and validation .
• Proficiency in MS Project and statistical tools like MINITAB .
• Knowledge of GD&T principles.
• CQE certification or equivalent training/experience is preferred.

Secondary Skills (Good to Have):

• Exposure to emerging technologies and current industry practices .
• Ability to learn quickly and work independently with minimal supervision.
• Strong verbal and written communication skills.

  Qualification:

  • Bachelor’s or higher degree in Biomedical Engineering or Pharmaceutical Sciences

Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.