Preventive & Unplanned Maintenance Coordinator

As a Preventive & Unplanned Maintenance Coordinator, your primary responsibility will be to ensure the effective execution and coordination of our established preventive maintenance schedules for a wide range of manufacturing equipment. By collaborating with various teams, you will play a pivotal role in maintaining the reliability and operational efficiency of our equipment, minimizing disruptions, and contributing to the timely delivery of critical medical devices to the market.

Key Responsibilities:

• Collaborate closely with production, engineering, and quality assurance teams to build and maintain a robust monthly preventative maintenance schedule for all manufacturing equipment.
• Coordinate with external vendors to establish and maintain annual service contracts, negotiate terms, and ensure timely execution of maintenance activities.
• Schedule necessary planned and unplanned equipment repairs, solicit quotes from vendors, and lead the issuance of purchase orders (POs) to authorize repair work.
• Generate nonconformance reports (NCRs) when equipment falls out of specification, working closely with the Quality Assurance team to address issues and implement corrective actions.
• Maintain the equipment management database, ensuring accurate and up-to-date records of all maintenance activities, repairs, and equipment specifications.
• Collaborate with cross-functional teams to manage the entire lifecycle of manufacturing equipment, from activation to obsolescence.
• Ensure that all preventative maintenance activities are carried out in full compliance with GMP regulations and company policies.
• Regularly audit and assess the effectiveness of preventative maintenance processes, recommending improvements where necessary.
• Provide support during regulatory inspections and audits by maintaining comprehensive and well-organized records.
• Communicate effectively with all stakeholders, ensuring alignment on maintenance schedules, repairs, and equipment status.

A day in this job may entail:

• Management of scheduling databases
• Working with cross-functional teams to coordinate equipment services.
• Working closely with vendors to schedule site visits.
• Review and filing of equipment documentation.

• May require some higher education or specialized training/certification, or equivalent combination of education and experience
• 1+ years' experience in equipment maintenance management or equivalent
• Effective communication and teamwork abilities to collaborate with various departments and stakeholders
• Demonstrated excellence in time management, organization, and the ability to effectively and efficiently handle multiple tasks and projects
• Proficiency in computerized maintenance management systems (CMMS) and Microsoft Office Suite

Preferred Experience:

• Creating Purchase Requisitions
• Customer Service Experience
• Proficient with SAP
• Familiarity with regulatory requirements and quality standards relevant to medical device manufacturing (e.g., ISO 13485, FDA guidelines)
• Experience managing vendors/suppliers/subcontractors