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4 months ago

Ambattur Chennai Tamil Nadu, India Techindia Infoway Pvt Ltd Full time

**QA/QC (Quality Assurance and Quality Control) medical devices**:
**Qualifications for QA/QC engineer**:
Work experience should be minimum 3 - 4 years in medical devices manufacturing.

**Responsibilities for QA/QC engineer**:

- To ensure quality management systems are implemented and maintained always Responsibilities
- To handle all activities related to quality management system, ISO 9001 & 13485, 93/42/EEC Directive including
- Technical files making & updating including risk management, clinical evaluation, post-market surveillance, quality plan, ESRs, etc.
- Fulfilment of regulatory requirements related to EC directive, various registration of overseas.
- Follow up of local regulatory & drugs requirements.
- Validation
- machines, processes, clean rooms, material & sterilization.
- Organizing internal & external audits including notified bodies audits related to quality management system & CE and follow up of non-closure reports.
- Dealing in customer complaints, investigating, root cause analysis and replying, vigilance reporting & recall.
- MRM- Organizing & follow up actions from previous meetings.
- Review & modification in all the SOPs & manuals.
- Master list of records
- Establishment & updating.
- Master list of documents
- Establishment & updating.
- Deviations
- Follow up & records
- Corrective & preventive actions
- Corrections, implementations & maintenance.
- Calibration of equipment and machines of production & quality control.
- Handling out the pre-dispatch inspections of shipments by the outside agencies and certification bodies.
- Training
- Planning & Imparting Requirements:

- Excellent computer skills
- Goal Oriented
- Strong communication skills, including the ability to explain and teach methodologies

**Job Types**: Full-time, Permanent

Pay: ₹211,596.69 - ₹1,082,132.04 per year

**Education**:

- Bachelor's (required)

Work Location: In person