Overview:
The Production Operator/Associate will be responsible for performing a variety of manufacturing tasks in compliance with the company's quality standards and regulatory requirements. This position focuses on the assembly, testing, and packaging of medical devices, ensuring they meet all specifications and quality controls. The ideal candidate should have experience working in a cleanroom environment and familiarity with Good Manufacturing Practices (GMP) in the medical device industry.
Key Responsibilities:
- Manufacturing Operations:
- Operate and monitor production machinery and equipment for assembling and manufacturing medical devices.
- Perform manual assembly tasks, including component placement, soldering, bonding, or fastening of device components.
- Conduct in-process checks and verifications to ensure product quality and adherence to specifications.
Quality Control:
- Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) for maintaining product quality.
- Inspect finished products for defects or deviations and ensure compliance with FDA and ISO 13485 regulations.
- Document production activities and report any deviations or equipment issues to supervisors.
Cleanroom Compliance:
- Work in a cleanroom environment, adhering to all gowning and safety protocols to avoid contamination.
- Maintain a clean and organized workspace, ensuring a safe and efficient working environment.
Collaboration & Communication:
- Work closely with quality control teams, engineers, and other production staff to resolve issues and improve processes.
- Communicate production progress and issues to supervisors and colleagues during shifts.
Qualifications:
- High School Diploma or GED required; additional technical training or certification in manufacturing is a plus.
- 1-3 years of experience in a manufacturing or production environment, preferably in the medical device, pharmaceutical, or related industries.
- Experience working in a cleanroom environment and knowledge of ISO and FDA standards.
- Ability to follow detailed instructions and operate machinery with precision.
- Basic knowledge of computer systems for data entry and production tracking.
- Strong attention to detail, manual dexterity, and ability to work with small components.
- Ability to stand for extended periods and lift up to 25 pounds.
Job Type: Contract
Pay: $18.34 - $19.14 per hour
Expected hours: 40 per week
Schedule:
- 8 hour shift
- Evening shift
- Monday to Friday
Experience:
- Medical Device: 1 year (Required)
- Production worker: 1 year (Required)
Ability to Commute:
- Austin, TX 78728 (Required)
Work Location: In person
