Cleanroom, Communication Skills, Computer Skills, Computer Software, Continuous Improvement, Data Collection, Detail Oriented, Documentation, Environmental Management Systems, Establish Priorities, Healthcare Quality, High School Diploma, Lean Manufacturing, Maintain Compliance, Manufacturing, Manufacturing Management, Medical Equipment, Medical Tests, Pacemaker, Procedure Development, Production Support, Quality Management, Quality Metrics, Regulations, Safety Standards, Testing, Traceability
Job Title: Operator I
Location: 6035 Stoneridge Dr, Pleasanton, CA 94588
Duration: 6+ Months Contract
Shift: 5:00 AM 1:30 PM
Job Summary
Seeking an Operator I to support the production of high-quality medical devices in a manufacturing environment. This role involves assembly, testing, inspection, and documentation activities while adhering to quality, safety, and regulatory standards.
Key Responsibilities
- Assemble, repair, and test medical devices, including pacemakers, ICDs, leads, and related components.
- Follow established manufacturing procedures and work instructions.
- Maintain accurate production, quality, and traceability documentation.
- Ensure compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and safety regulations.
- Support continuous improvement and Lean Manufacturing initiatives.
- Communicate effectively with team members and manufacturing management.
- Handle small components with precision and maintain high-quality standards.
- Utilize electronic data collection systems and computer software as required.
Required Qualifications
- High School Diploma or equivalent.
- Ability to read and follow written procedures and verbal instructions.
- Basic computer skills and experience with electronic documentation systems.
- Strong attention to detail and ability to work in a regulated manufacturing environment.
- Ability to prioritize tasks and make sound decisions with minimal supervision.
- Comfortable working with small parts and performing repetitive tasks.
Work Environment & Dress Code
This position requires adherence to strict cleanroom/manufacturing attire and grooming standards, including:
- Non-shedding, clean clothing free of loose fibers or contamination.
- Closed-toe, closed-heel shoes with heels under 2 inches.
- No nail polish, artificial nails, jewelry, body piercings, makeup, fragrances, or scented products.
- Hair coverings and protective garments must be worn as required.
- Compliance with all safety, cleanliness, and contamination-control guidelines.