Job Title: QA/RA Engineer - Medical Devices

Location: Vadodara, Gujarat (Onsite)

Job Type: Full-Time

Required Work Experience – 4 to 10 Years

About SILMATES:

Silmates Private Limited is Service provider company working in the Medical Equipment domain. We are working with our offshore clients for the NPD, Sustenance engineering, Testing, V&V activities for their existing and under development products, on the area of Electrical and Electronics, Mechanical, Software fronts.

We are also working with clients for their end to end (Concept to Market) product development needs especially in medical domain.

Job Summary: The QA/RA Engineer will be responsible for overseeing quality assurance and regulatory affairs activities related to the development, manufacturing, and distribution of medical products. This role requires a strong understanding of regulatory requirements, quality management systems, and product lifecycle management, with a particular focus on handling FDA queries and resolutions.

Key Responsibilities:

·      Quality Assurance:

·      Experience remediating medical device documentation to meet medical device quality guidelines.

·      Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 13485 and other relevant standards.

·      Execute non-conformance reports (NCRs), corrective and preventive actions (CAPA), and root cause analysis.

·      Regulatory Affairs:

·      Perform regulatory assessment of medical device design changes to existing submissions as part of change management.

·      Prepare and submit regulatory documentation for product approvals, renewals, and changes (FDA, CE Mark, etc.).

·      Monitor and interpret regulatory changes and ensure company compliance.

·      Product Development Support:

·      Provide QA/RA input during product development and design control processes.

·      Evaluate medical device complaints for FDA or MDR reporting requirements in accordance with client company procedures and Regulatory requirements.

·      Perform the preliminary classification and categorization of complaints and escalate complaints that require additional review.

·      Review and approve design and development documentation to ensure compliance with regulatory standards.

·      Ensure risk management processes are followed and documented.

·      Train engineering staff on quality management system.

·      Documentation and Training:

·      Maintain accurate and comprehensive documentation related to quality and regulatory activities.

·      Develop and deliver training programs on quality and regulatory requirements for staff.

Qualifications:

·      Bachelor's degree in Engineering, Bio-Medical, Life Sciences, or a related field.

·      Minimum of 3-5 years of experience in quality assurance and regulatory affairs within the medical device or pharmaceutical industry.

·      In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.

·      Proven experience in handling FDA queries and resolving regulatory issues

·      Experience with QMS implementation and management.

·      Strong analytical, problem-solving, and organizational skills.

·      Very good verbal and written communication skills in English is a must.

·      Certification in quality management (e.g., CQE, CQA) or regulatory affairs (e.g., RAC) is a plus.

Benefits:

·      Competitive salary and benefits package.

·      Opportunities for professional growth and development.

·      Collaborative and innovative work environment.

How to Apply: Interested candidates should submit their resume and cover letter to [email protected].