Overview
Responsible for assembling high quality medical devices in accordance with approved manufacturing process instructions and Standard Operating Procedures, assisting in the evaluation and resolution of line issues, and suggesting possible method / process improvements. Other job duties will be assigned as needed.
Responsibilities
- Adhere to safety rules, stretching exercises, and company policies and procedures.
- Assemble product as required utilizing small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
- Identify and communicate any safety, quality, process issues or concerns as needed.
- Maintain controlled environment integrity by using proper attire and adherence to controlled environment practices and procedures.
- Perform in-process quality checks as required while giving timely feedback as issues arise
- Recognize and report any unacceptable materials and/or sub-assemblies to engineering and/or supervisor.
- Responsible for 100% compliance to Endologix Quality and Regulatory policies and adhere to Endologix Core Values.
- Responsible for quality of work and adhering to manufacturing methods and quality records.
- Understand and comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Work with supervisors, engineers and technicians to resolve line issues and suggest improvements.
- Participate in lean activities and 5S improvement efforts.
- Be familiar with terminology used in the production area.
- Aware of common defects within manufacturing departments and the results caused by variations during the manufacturing processes.
- Capable of moving from one station to another without continuous mistakes.
- May be certified as a trainer and train other production employees on manufacturing processes.
- Capability to read and interpret engineering drawings, specs and method sheets.
- Electronic systems entry
Qualifications
- Demonstrates basic English reading, writing and spoken skills
- Basic Math
- Work with small components, adhesives, and microscopes
- Experience working in a CER a plus
