Building Maintenance Worker (Cleveland)

• 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

• Position is on-site, this is NOT a remote or hybrid position
• May be required to stand for long periods of time
• Visual acuity to examine specimens and reagents
• The ability to distinguish colors
• Light lifting may be required; offices reachable by elevator but should be able to climb stairs in case elevator out.
• May be exposed to hazardous chemicals, biohazards, radioactive materials, etc.
• Candidate must have ability to maintain punctual daily in-person attendance

• 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
• Salary range may vary by work state/geographical region/territory
• Easy to get to office location with newly built-out office space
• Free coffee, snacks and other goodies all day long

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