Job Title

Officer / Sr. Officer

Location

Pardi, Gujarat, India

Responsibilities

- Execute day-to-day manufacturing of urology medical devices.
- Prepare and maintain Batch Manufacturing Records (BMR) and production documentation.
- Ensure compliance with ISO 13485, GMP, and company Quality Management System.
- Coordinate with QA, QC, RD, Engineering, and Supply Chain for smooth production.
- Monitor production output, yield, rejection, and machine utilization.
- Support process validation (IQ/OQ/PQ) and manufacturing transfers from RD.
- Implement process improvements to enhance productivity and reduce waste.
- Ensure line clearance, traceability, and product identification throughout manufacturing.
- Participate in deviation, CAPA, NCR, and root cause investigations.
- Train operators on manufacturing procedures and positive documentation practices.
- Maintain 5S, safety, and cleanroom discipline in production areas.

Requirements

- Bachelors Degree in Biomedical Engineering, Mechanical Engineering, Production Engineering, or related discipline.




- Preferred: 1-5 years of experience in medical device manufacturing.

Technical Skills Required

- Medical device manufacturing processes
- ISO 13485 GMP
- Good Documentation Practices (GDP)
- Process Validation (IQ/OQ/PQ)
- Lean Manufacturing 5S
- Root Cause Analysis (5 Why, Fishbone)
- SAP/ERP production transactions
- Microsoft Excel production reporting

Competencies

- Strong analytical and problem-solving ability
- Cross-functional collaboration
- Attention to detail
- Communication skills
- Ownership and accountability
- Continuous improvement mindset

Job Details

- Work Experience: 1-3 years
- Job Type: Full time

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Officer / Sr. Officer (Killa-pardi)
🏢 Meril
📍 Killa-pardi