Production Operator Assembler- 2nd shift

Shift Available: 2nd Shift: 2:00 pm-12:30 am Monday-Thursday

Responsibilities

Core Responsibilities (Applies to All Areas)

• Complete detailed documentation and ensure compliance with ISO/cGMP standards.
• Participate in continuous improvement initiatives and suggest process enhancements.
• Crosstrain and assist in onboarding new team members.
• Maintain an organized, clean work area following 5S expectations.
• Participate in required training and company meetings.
• Read, understand, and follow work instructions, standard work, and applicable quality/ISO/cGMP requirements.
• Support and comply with the Quality System, ISO, and medical device regulatory requirements.
• Communicate issues with materials, equipment, or processes promptly.
• Perform other duties as assigned.

The following responsibilities may vary by operating company and may not apply in all cases. Other responsibilities may also be assigned, but are not listed below.

Assembly Responsibilities

• Assemble and package components and medical devices with increased complexity per specifications.
• Operate advanced manual and semi-automated equipment.
• Perform in-process quality checks and resolve minor assembly issues.

Production Operations Responsibilities

• Set up and operate production equipment, including loading programs and adjusting parameters.
• Monitor and troubleshoot machine performance and escalate issues as needed.
• Perform operator-level preventive maintenance.

Secondary Operations Responsibilities

• Execute advanced secondary operations (e.g., trimming, deburring, cleaning, passivation, laser marking, laser welding, label generation & inspection, and/or finishing of components).
• Use precision measurement tools (micrometers, digital calipers) for verification.

Qualifications

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

• 1+ years of manufacturing, assembly, machine operation, or cleanroom experience.
• Ability to work in a manufacturing environment.
• Ability to read, write, and follow written instructions in English.
• Ability to read technical drawings and interpret specifications.
• Strong troubleshooting and problem-solving skills.
• Perform basic math, hand–eye coordination, and dexterity.
• Ability to use basic hand tools and measurement equipment.
• Clear and effective verbal and written communication skills.
• Strong attention to detail and organizational skills.
• Ability to work in a fast-paced team environment and handle multiple tasks.
• Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).

Desirable Criteria & Qualifications

• High school diploma or equivalent.
• Familiarity with FDA, ISO, cGMP, Lean manufacturing, or workplace safety practices.
• Experience working with microscopes or inspection tools.
• Experience with semi-automated equipment and advanced inspection tools.
• Familiarity with Lean manufacturing principles.

Physical & Environmental Demands: Cretex Companies use cutting oils, solvents, and other chemicals in the manufacturing process. Testing is conducted on a periodic basis to ensure that all chemicals are kept well below the OSHA permissible exposure levels.