MedTech Packaging & Labeling Specialist I

ADP, Inc.; Belgrade (MT); On-site; USD 70,000 - 90,000; Full time

Job summary

Xtant Medical, based in Belgrade, MT, is seeking a regulatory and quality-focused professional to ensure compliance with FDA and ISO standards for biomedical products. The role collaborates with the department team lead and manager to uphold cGMP, GDP, and safety protocols in a production/QA environment.

Ideal candidates will have strong attention to detail, familiarity with SOPs, and the ability to work in a fast-paced setting while maintaining confidentiality of donor and recipient information

Qualifications

• High School Diploma or equivalent is required.
• Two to four years of college preferred.
• Experience with SOP, Document Control, and/or regulated environment is preferred.
• Basic knowledge of anatomy and aseptic techniques is preferred.

Responsibilities

• Develop and maintain understanding of industry standards including 21 CFR 820, 21 CFR 1271, AATB, MDSAP, and ISO 13485.
• Actively contribute to the fulfillment of Xtant Medical’s mission, values and quality policy.
• Maintain a safe, clean work environment and ensure proper disposal of hazardous and non-hazardous waste per OSHA guidelines and SOP.
• Develop and maintain an understanding of Xtant Medical products.
• Understand the interaction of departmental activities with the Quality System and their impact on the production of medical devices and HCT/Ps.
• Adhere to GDP, GDP, and safety protocols (note: GDP stands for Good Documentation Practices).
• Follow OSHA Blood Bourne Pathogen Standards, Universal Precautions, AATB Standards, cGMP, and cGTP.
• Assist in the QC functions of examining and inspecting labels and finished goods to ensure packaging specs are met per SOPs.
• Assist in processing paperwork to establish expiration dates for processed tissue and devices per SOPs.
• In a team environment, assist in sterilization processes for product and raw materials.
• Learn and maintain knowledge of product lines and codes.
• Use equipment such as industrial label printers and sealers and common office equipment.
• Assemble finished goods with labeling materials and print labels using barcode software.
• Coordinate shipping and receiving of materials as needed.
• Help maintain appropriate inventory levels within ERP.

Skills

Independent reasoning

Data interpretation

Written and oral communication

Organizational skills

Adaptability

Attention to detail

Education

High School Diploma or equivalent

2–4 years of college preferred

SOP & Document Control experience

Anatomy & aseptic techniques knowledge

Job description

Xtant Medical, based in Belgrade, MT, is seeking a regulatory and quality-focused professional to ensure compliance with FDA and ISO standards for biomedical products. The role collaborates with the department team lead and manager to uphold cGMP, GDP, and safety protocols in a production/QA environment.

Ideal candidates will have strong attention to detail, familiarity with SOPs, and the ability to work in a fast-paced setting while maintaining confidentiality of donor and recipient information