Job Description
Job Overview:
- Assemble, package, and label medical devices precisely following GMP, SOPs, and quality standards.
- Operate and monitor manufacturing equipment, adhering to batch records and work instructions.
- Perform visual inspections during and after production to confirm product quality.
- Accurately complete documentation, including batch records and production logs, in compliance with regulatory requirements.
- Review and verify batch records for accuracy and completeness.
- Meet or exceed daily production targets and report performance metrics.
- Maintain material readiness and manage non-conforming materials according to procedures.
- Keep work area clean and organized, following 5S and cleanroom protocols.
- Use personal protective equipment and comply with all safety requirements.
- Communicate production issues, risks, or deviations promptly to leadership.
- Support calibration, validation, and other manufacturing activities as needed.
- Participate in training new team members and contribute to knowledge sharing.
- Engage in continuous improvement initiatives and provide backup support as required.
- Follow all company policies and regulatory guidelines.
[Required Skills and Experience]
- High School Diploma or GED required.
- Minimum 5 years’ experience in a manufacturing or production environment.
- Strong attention to detail and ability to follow detailed instructions.
- Comfortable working in a cleanroom or controlled environment with PPE.
- Solid communication skills; ability to document clearly and work as part of a team.
