Operator

About the role

We are seeking a meticulous and quality-minded Operator to support the manufacturing of our bone graft product families in a production Laboratory and/or Cleanroom setting. The role is critical to ensuring product quality, traceability, and compliance throughout the production process.

Responsibilities

• Support the commencement of our new manufacturing facility in Alpharetta, Georgia.
• This includes traveling to our Bilthoven, Netherlands manufacturing location for on-the-job training and knowledge transfer.
• Support the Execution of our IQ/OQ/PQ validation process prior to go-live of our new manufacturing.
• Support the development and continuous improvement of our training program.
• Perform manual and semi-automated assembly of our Magnetos product family in an ISO Class 8 cleanroom and controlled lab environment.
• Follow detailed work instructions, standard operating procedures (SOPs), and batch records accurately.
• Operate and maintain cleanroom equipment and tools (e.g., graduated cylinders, vibration tables, scales, vacuum sealers, ovens, dispensers).
• Perform in-process inspections to verify quality specifications.
• Handle sterile or non-sterile packaging and labeling of finished products, ensuring lot control and traceability.
• Maintain cleanroom gowning protocols and adhere strictly to contamination control and hygiene standards.
• Accurately complete production documentation, including batch records, in compliance with FDA 21 CFR Part 820 and ISO 13485.
• Report deviations, non-conformances, or equipment malfunctions to quality personnel promptly.
• Support cleaning, calibration, and routine maintenance of equipment and cleanroom areas.
• Collaborate with Quality, Process Development Engineering, R&D and Production teams on continuous improvement initiatives and process validations.

Qualifications

• Education: Bachelor’s degree in Biology, Chemistry Engineering, Biology, or related field required.
• Leverage Lean Six Sigma Green Belt Certification preferred.
• Experience: 0-2+ years in Operations within an ISO13485 regulated industry.
• Experience working in an ISO 7 or ISO 8 cleanroom manufacturing process.
• Experience working with lean manufacturing principles and with in a 6S program.
• Skills: Strong attention to detail and ability to follow precise work instructions. Excellent communication and interpersonal abilities. Understanding in lean methodologies, Six Sigma tools and working within a 6S program. Proficiency within an ERP or MES systems, preferably in Microsoft Dynamics 365.

Physical Requirements and Work Conditions

• Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
• Lifting/Carrying: May require lifting and carrying items 50 pounds or more, depending on the role.
• Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.
• Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver’s license.