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Job Description & How to Apply Below
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 / bachelor’s degree in mechanical, Chemistry or related discipline.
Experience:
1–4 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
Position Requirements
10+ Years
work experience
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