Associate– Production- Laser Cutting

Job Purpose

To operate and monitor laser cutting machines for stent manufacturing, ensuring precise production, in-process quality control, accurate documentation, and compliance with ISO 13485 and GMP requirements.

Key Responsibilities

• Operate, set up, and monitor laser cutting machines and related processes used in stent manufacturing .
• Perform in-process inspections of laser-cut stents to ensure dimensional accuracy and compliance with approved specifications.
• Maintain, update, and control production documents and records in line with ISO 13485 and internal QMS requirements.
• Issue Batch Manufacturing Records (BMRs) in accordance with approved production planning .
• Submit batch rejection details and non-conformance information to the Quality Assurance (QA) department in a timely manner.
• Ensure accurate and complete transfer of BMRs to the next manufacturing process after completion of each production stage.
• Monitor, record, and maintain environmental conditions (temperature, humidity, cleanliness) in the laser cutting area within specified limits.
• Plan and organize daily work activities to enhance productivity, efficiency, and output without compromising product quality.
• Prepare and submit shift-wise production reports and communicate production status to the Manager at the end of each shift.
• Follow Good Manufacturing Practices (GMP) , safety procedures, and company policies at all times.
• Support internal, customer, and regulatory audits as and when required.

Qualifications & Experience

• Education: Diploma / bachelors degree in mechanical, Chemistry or related discipline.
• Experience:
• 14 years of experience in laser cutting operations , preferably in medical device, precision engineering, or regulated manufacturing environments.
• Exposure to stent manufacturing will be an added advantage.

Skills & Competencies

• Knowledge of laser cutting machines and parameters
• Understanding of ISO 13485, GMP, and in-process inspection
• Ability to read and follow engineering drawings and specifications
• Strong documentation and record-keeping skills
• Basic computer literacy and ERP/SAP exposure preferred
• Attention to detail and quality orientation
• Good communication and teamwork skills