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Consumables Production Specialist

2 months ago

Chelmsford, Massachusetts, United States First Light Diagnostics Full time

Job Overview:

The role of the Consumables Production Specialist involves a proficient individual tasked with executing manufacturing operations related to consumables, which includes the assembly, packaging, and kitting of cartridges, controls, and other consumables to support product development and sales initiatives. This encompasses all assembly-related tasks such as parts inspection, reprocessing as needed, inventory oversight, and identifying opportunities for process enhancements.

Core Responsibilities and Essential Skills:

  • Conducting inspections and reprocessing of incoming components to ensure compliance with quality standards before they are deemed suitable for inventory.
  • Manufacturing sub-assemblies, intermediates, and finished consumables in accordance with regulatory standards such as 21 CFR part 820 and ISO 13485.
  • Accurately populating moisture-sensitive and delicate lyophilized beaded reagents into fluid cards, requiring sustained focus and precision in a dynamic environment.
  • Maintaining meticulous quality records to ensure that manufacturing activities are executed as designed for their intended applications.
  • Executing consumables manufacturing tasks within established timelines.
  • Collaborating effectively with team members and other departments to fully understand manufacturing requirements for both standard and custom products.
  • Engaging in dual control inspection processes as outlined in manufacturing protocols to ensure multiple verification points throughout the workflow.
  • Operating automated or semi-automated machinery to enhance manufacturing efficiency as necessary for scaling operations.
  • Reporting any discrepancies to supervisors and management to mitigate potential failures resulting from defective components or inefficient processes.

Qualifications and Experience:

  • A High School Diploma with relevant experience in biotech manufacturing or a similar field is preferred. An Associate degree in Engineering or a related technical area is desirable.
  • A minimum of 1-2 years of experience in medical device manufacturing or a related industry is required.
  • Effective verbal and written communication skills to articulate manufacturing issues clearly.
  • Proficient problem-solving abilities to troubleshoot manufacturing challenges and contribute to continuous improvement in a fast-paced environment.
  • Capacity to manage the demands of a rapidly changing work environment where priorities may shift frequently.
  • Strong interpersonal skills and a collaborative spirit to work effectively with colleagues in a diverse cultural setting.