Quality Assurance (QA) Manager jobs at chennai
Salary gross: 45k  to 50k
Department:  Quality
Designation:  Quality Assurance engineer
EXP : 10 years
No.of vacancy :2
 Edu : BE / DIP
 Location: Ambattur
Gender: Male 
Age Limit: 24 to 45 years
Shifts:  8 hrs 
Skills:
Documentation knowledge
 Candidates have relevant experience can contact below mention number
RIYA -HR
8148847214

Roles and Responsibilities:
• Develop and implement quality assurance strategies and processes to ensure compliance with CE, US FDA, and EU MDR regulations.
• Establish and maintain quality management systems to support product development, manufacturing, quality and distribution processes.
• Conduct audits and inspections to ensure adherence to regulatory requirements and medical quality standards.
• Provide guidance and training to employees regarding quality assurance procedures, regulations, and documentation requirements.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality is built into product development and manufacturing processes.
• Lead risk management activities and ensure appropriate mitigation measures are in place.
• Oversee the validation of manufacturing and sterilization processes.
• Manage the documentation process, including the creation, review, and approval of quality-related documents, such as standard operating procedures (SOPs), work instructions, and validation protocols.
• Monitor and analyze quality metrics to identify trends, implement corrective actions, and drive continuous improvement.
• Serve as the primary point of contact for regulatory agencies during inspections and audits.
• Stay up to date with evolving regulations, industry standards, and best practices related to medical device quality assurance.
• Responsible for Quality Assurance Documentation and quality of the products for product release.