Quality Assurance @ Sanand (Medical Device Industry)

Educational Qualification: Candidate should possess Bachelor's Degree in Mechanical Engineering

Required Experience : Candidate should possess 4 Years of experience in Medical Device Organization.

Skill Required : Computer Proficient (Microsoft Office)

Language Proficiency : English, Hindi, Gujarati

Job Knowledge:

• Perform Installation Qualification, Operational Qualification and Performance Qualification activities
• Collect data during validation activities and performing basic test on equipment and processes under guidelines.
• Execute validation protocols for equipment, processes and system to ensure they meet industry regulations.
• Prepare validation documents such as protocols, test plans and reports, ensuring proper filing and maintenance of documents.
• Record test results, deviations and corrective action accurately and support the review of validation data.
• Ensure validation documentation complies with international standards and regulatory requirements.
• Adhere to GDP and internal quality management system while performing validation task.
• Ensuring compliance with ISO 13485, and other relevant regulatory guidelines in validation activities.
• Preparation of documents and records for internal and external audits.
• Addressing audit findings or corrective actions related to validation processes.
• Collaborate with cross functional teams, including manufacturing, engineering and quality assurance in validation activities.
• Control of record and documents as per QMS
• Prepare SOP and Quality procedure as and when required
• Review and compile Device History Records
• Prepare change control as and when required
• Review external test reports according to requirements
• Review equipment calibration certificates and assist calibration engineer as and when required
• Review and update calibration documents as per plan
• Coordinate with different departments for QA activities
• Other work assigned by superior

If you are interested kindly share your cv
6353 076 225

Job Type: Full-time

Pay: 350,000.00 - 500,000.00 per year

Schedule:

• Day shift

Education:

• Bachelor's (Preferred)

Experience:

• total work: 1 year (Preferred)

Work Location: In person