Manufacturing Technician

Cleveland Diagnostics-posted 4 days ago
Full-time • Entry Level
Onsite • Cleveland, OH
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Cleveland Diagnostics is a dynamic and innovative company dedicated to the development of cutting-edge diagnostic solutions. We are committed to improving healthcare through the creation of highly accurate and reliable diagnostic tests. We foster a collaborative and supportive team environment where individuals can grow and contribute to meaningful scientific advancements. We are seeking a highly motivated and detail-oriented Manufacturing Technician to join our growing team. The Manufacturing Technician will be responsible for performing various tasks according to established procedures. These tasks include reagent formulation, filling, assembly, packaging, material handling, in-process quality checks, adherence to safety protocols, accurate documentation, and support for continuous improvement initiatives. This position requires strong attention to detail, strict compliance with FDA cGMP and ISO 13485 regulatory requirements, and the ability to perform effectively in a dynamic, high-throughput, and highly regulated manufacturing environment.

  • Formulation, Filling, and Packaging of Class III medical devices according to SOPs, work instructions, and product specifications, ensuring compliance with GMP, FDA, and ISO 13485 standards.
  • Operate and maintain production equipment and perform material staging, line setup, changeovers, and cleaning procedures.
  • Assist in preventive maintenance, equipment calibration support, and basic troubleshooting of equipment.
  • Maintain clean, organized, and compliant work and storage areas, following cleanroom protocols, PPE requirements, and safety guidelines.
  • Support adherence to environmental and hazardous waste handling requirements as outlined by local and federal regulations.
  • Receive, inspect, label, and store raw materials and components, ensuring accurate lot control, FIFO/FEFO usage, and traceability in accordance with inventory procedures.
  • Issue and return materials to/from production using inventory management systems, maintaining real-time inventory accuracy and proper documentation.
  • Conduct physical inventory counts, cycle counts, and material reconciliations of the raw materials and components.
  • Conduct the preparation of finished products for shipment, including packing, labeling, and ensuring that all items are ready for transportation.
  • Coordinate shipping, ensuring the correct materials are shipped on time to meet customer requirements.
  • Assist in the creation, revision, and control of SOPs, work instructions, and training documents to ensure they reflect current processes and regulatory requirements.
  • Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) by completing accurate, timely, and legible documentation (e.g., logbooks, device history records).
  • Assist in identifying, documenting, and escalating non-conformances (NCRs) and supporting root cause investigations and Corrective/Preventive Actions (CAPAs).
  • Support internal and external audits by preparing documentation, maintaining inspection readiness, and answering auditor queries.
  • Contribute to lean manufacturing initiatives, such as 5S, waste reduction, and process optimization, to enhance product quality and reduce downtime.
  • Other duties as assigned
  • Associate degree in Engineering Technology, Life Sciences, Manufacturing, or a related technical field.
  • Minimum of 2 years of experience in a regulated manufacturing environment (medical device, pharmaceutical, or biotech preferred).
  • Hands-on experience with FDA, ISO 13485, or GMP-compliant processes is highly desirable.
  • Following Strong working knowledge of FDA regulations (21 CFR Part 820), ISO 13485, GMP, and GDP standards.
  • Proficiency in reading and following SOPs, technical drawings, and product specifications.
  • Solid problem-solving skills with the ability to identify quality issues and contribute to resolution efforts.
  • Familiarity with ERP or inventory systems for production and material tracking.
  • Strong attention to detail, documentation accuracy, and organizational skills.
  • Ability to work independently and in cross-functional teams in a fast-paced environment.
  • Effective written & verbal communication skills
  • Proficient computer skills especially with Microsoft applications (Word, Excel, PowerPoint)
  • Ability to manage & prioritize workload effectively
  • COVID-19 vaccination is recommended
  • Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples).
  • 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
  • 100% Employer-paid Dental & Vision for entire family
  • No cost for employee coverage for Group Term Life, Short & Long Term Disability
  • 4% retirement contribution Employer match
  • Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
  • Paid Family Leave Program
  • Generous PTO plan & holiday program
  • Flexible work schedule & lucrative employee referral program
  • Free coffee, snacks and other goodies all day long
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