Manufacturing ​/ Production Operator, Quality Engineering

Position Summary:
The Operator I is responsible for producing high-quality medical devices within a manufacturing cell. Working under close supervision, this role involves a combination of assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related assemblies.

Key Responsibilities:

• Perform routine assignments following standardized procedures, with work reviewed continually.

• Ensure accuracy of job documentation, traveler records, and quality documents.

• Communicate clearly and effectively (both written and verbal) with all levels of manufacturing management.

• Maintain a professional and positive attitude when interacting with internal and external stakeholders (e.g., customer tours).

• Adhere to safety guidelines and use proper safety equipment.

• Participate in continuous improvement and quality initiatives to enhance processes and meet quality/profitability goals.

• Apply Lean Manufacturing principles.

• Collaborate with Supervisor/Manager in setting and monitoring goals and cell performance metrics.

• Support divisional initiatives including Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance.

Required Skills & Abilities:

• Ability to read, comprehend, and follow written procedures and verbal instructions.

• Proficiency in electronic data collection systems and basic computer software.

• Ability to prioritize tasks and manage sequencing based on importance.

• Fine motor skills to handle and maneuver small components.

• Ability to make decisions and judgments with minimal supervision.

Education:

• High school diploma or equivalent preferred.

Dress Code & Cleanroom Requirements:

• Clothing must be non-shedding, free of loose threads, tassels, glitter, sequins, or similar dislodging materials.

• Sweaters, fleece, or loose-knit garments are not allowed.

• Clothing must fit under a lab coat/gown (no turtlenecks, high collars, or sleeves beyond the gown cuff).

• Head coverings must comply with safety and gowning requirements.

• Shoes must be closed-toe, closed-heel, with heels no higher than 2 inches (sandals, clogs, slippers, or woven/strap shoes not permitted).

• Stockings or socks are required.

• No nail polish, artificial nails, or similar coatings.

• Jewelry or piercings that could pierce gloves or are exposed are not permitted.

• No makeup; lip balm in stick form allowed (applied outside production areas).

• No scented personal products, except deodorant.

• Lotions must not be applied after hand washing.

• All wounds must be securely bandaged.

• Clothing and appearance must remain professional and non-offensive.