Job Description

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is

no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products. At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility,

teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

A Packaging and Boxing Supervisor oversees the final stages of production, packing, labeling, and boxing sterile or non-sterile medical devices and components. They ensure all packaging activities meet strict Quality Management Systems (QMS), cGMP (current Good Manufacturing Practices), and FDA standards while maintaining safety and productivity goals. This role bridges management and production staff, supervising 8-20 or more employees to ensure on-time delivery, accurate batch documentation, and proper equipment operation.

Job Responsibilities

• Manage daily packaging operations, including staff scheduling, line assignments, and performance monitoring to meet production goals.
• Ensure all packing and boxing activities comply with ISO standards, FDA regulations, and company SOPs (Standard Operating Procedures).
• Inspect finished packages for complete seals, correct labeling (lot numbers, expiration dates), and accurate box counts, particularly for sterilization.
• Review and approve packaging batch records and Device History Records (DHR) to ensure they are "right the first time".
• Train, mentor, and evaluate packaging staff, fostering a safety-first culture and addressing performance concerns.
• Coordinate with maintenance technicians for machine repairs and ensure packaging equipment (e.g., fillers, labelers, sealers) is cleaned, calibrated, and maintained.
• Lead 5S initiatives and use lean manufacturing principles to reduce waste and optimize line efficiency.
• Ensure a clean and organized work area to meet safety (OSHA) regulations and audit readiness.
• Demonstrates the ability to work and think quickly on their feet, effectively responding to changing priorities, production issues, or quality concerns in real time.

Requirements

Education / Certifications

• High School Diploma or GED required.
• Bachelor’s degree in Engineering, Business, or Science is preferred.

Job Requirements

• Typically 2–5 years of experience in packaging supervision, preferably within medical devices, pharmaceuticals, or a sterile manufacturing environment.
• Strong understanding of packaging equipment and automated machinery; familiarity with ERP systems (like NetSuite) and MS Office.
• Proficiency in FDA regulations, cGMP/GDP, and documentation practices.
• Strong leadership, communication, troubleshooting, and conflict resolution skills.
• Ability to stand for prolonged periods, walk, and regularly lift up to 10–30 pounds, with occasional lifting of heavier loads.
• Must be able to transition seamlessly between clean room and non-clean room environments, complying with all gowning, safety, and procedural requirements.
• Possess strong communication skills to coordinate effectively with cross-functional partners, including Quality, Engineering, Maintenance, Production, and Supply Chain.
• Able to provide clear direction, escalate issues appropriately, and ensure alignment across functions to support production goals and compliance requirements.