Administration & Document Control Manager

Job Title: Administration & Document Control Specialist (Medical Devices)

About Us:

We are a dynamic, ISO 13485-certified manufacturer specializing in high-quality lateral flow tests. Our mission is to deliver reliable diagnostic solutions that impact lives globally. As we grow, we are looking for a highly organized, detail-oriented Administration & Document Control Specialist to be the operational backbone of our office, ensuring our logistics, documentation, and administrative processes run flawlessly.

The Role:

In this critical role, you will be the bridge between our operations, quality, and administrative functions. You will work closely with our QA and QC departments to ensure all imports, shipments, and inventory processes maintain strict compliance with our Quality Management System (QMS). If you are a proactive problem-solver with a passion for meticulous document control and seamless office operations, we want to hear from you!

Key Responsibilities:

Document Control & Quality Compliance (Core Focus):

• Serve as the primary custodian of our document control processes, ensuring all QMS documentation, shipping records, and financial records are properly controlled for traceability.
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• Collaborate directly with QA and QC teams to ensure all incoming/outgoing shipments and inventory processes meet strict ISO 13485 regulatory standards.
• Maintain accurate and audit-ready records of product components and finished goods.

Logistics & Inventory Management:

• Coordinate complex logistics processes, including domestic and international shipments, deliveries, and tracking.
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• Manage import documentation and liaise with customs, carriers, and stakeholders to ensure timely and compliant deliveries.
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• Partner with supply chain and production teams to monitor inventory levels and ensure uninterrupted production flow.

Office Administration & Finance:

• Manage day-to-day office operations, including the procurement and management of office and laboratory supplies.
• Handle financial administrative tasks, including processing invoices, maintaining vendor records, and monitoring accounting inconsistencies.
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• Support financial decision-making by securely managing and organizing operational data.

Qualifications & Skills We’re Looking For:

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• Experience: Proven experience in an administrative, logistics, or document control role within a regulated environment (Medical Device, Pharma, or Biotech preferred).
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• Regulatory Knowledge: Strong understanding of ISO 13485 requirements, specifically regarding document control, traceability, and QMS compliance.
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• Organizational Mastery: Exceptional organizational and communication skills, with an unwavering attention to detail.
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• Tech-Savvy: Proficiency in inventory management systems, ERP software, and MS Office Suite.
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• Mindset: A proactive team player who thrives in a fast-paced environment and can confidently interface across multiple departments.

Why Join Us?

• Be a crucial part of a company making a tangible difference in global diagnostics.
• Work in a collaborative environment where your organizational skills directly impact product quality and company success.
• Opportunities for professional growth within a structured and expanding medical device company.