Manufacturing ​/ Production Operator, Quality Engineering

Overview

Operator II — Temecula, CA 92591
• 12 MONTHS
• Start Time 5:00–6:00 AM;
End Time 1:30–2:30 PM

This position is responsible for the production of high quality medical devices within a manufacturing cell. Working under close supervision, you may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. You will perform routine assignments according to specified and/or standardized procedures, with work closely reviewed. Maintain accurate records and ensure parts are traceable and quality issues can be addressed to assure product quality.

• Perform assembly, repair, and test operations on medical device assemblies per procedures.
• Maintain accurate documentation for cell operations, travelers, and quality records.
• Communicate ideas, problems, and solutions to manufacturing management in written and oral form.
• Maintain a positive posture in interactions with internal and external customers (e.g., tours).
• Follow safety guidelines and use appropriate safety devices during all operations.
• Participate in continuous improvement/quality initiatives to enhance production processes and meet quality and profitability metrics.
• Ensure product quality through traceability and timely issue resolution.
• Demonstrate a basic understanding of Lean Manufacturing.
• Assist Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics.
• Support divisional initiatives related to QMS, EMS, and other regulatory requirements.
• Read, comprehend, and follow written procedures; understand and follow verbal instructions.
• Utilize electronic data collection systems and computer software as required.
• Prioritize work by sequencing and timing based on precedence and importance.
• Handle and maneuver small components and parts.
• Make critical decisions and judgments with minimal supervision.

• High school degree or equivalent required.
• Ability to read, comprehend, and follow procedures; ability to follow verbal instructions.
• Ability to work with electronic data collection systems and computer software.
• Ability to prioritize and manage multiple tasks; attention to detail.
• Ability to work with small components and parts; capability to operate in a cleanroom/regulated environment as required.

Required dress code for tours during interview and on the job: clothing must be non-shedding and free of frayed hems or loose threads. Prohibited items include tassels, fringes, glitter, sequins, and any items that could become dislodged. Verify fabric by testing for loose fibers. Prohibited clothing includes loose fibers, loose-knit garments, fleece, or clothing that cannot be fully covered by lab coats/gowns.

All clothing must be clean and free of visible contamination. Clothing from the waist up must fit under the lab coat/gown; necklines and sleeves must comply with gowning requirements. Caps, hats, scarves, or bandanas are not allowed under the bouffant; head wraps must be covered by the bouffant and lab coat/gown. Loose-fitting clothing around machinery or soldering/brazing areas is prohibited.

Closed-toe, non-slip shoes are required; sandals and open-toed shoes are not allowed. Ensure proper gowning procedures when entering production areas.

Nail polish or artificial nails are not allowed. Jewelry or body piercings that could compromise glove integrity are not allowed in production areas. Makeup and scented products are discouraged; hand hygiene and wound coverage guidelines apply. If applicable, lip balm is allowed outside production areas and prior to hand washing. Prioritize safe, clean, and compliant attire at all times.

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