HIGHPOWER is a validation and testing lab for reusable medical devices that require cleaning, packaging, and sterilization procedures to complete their instructions for use. HIGHPOWER is an ISO 17025 accredited lab. As the Operations Manager, I supervise study directors, the laboratory supervisor and technicians, shipping and receiving, and building and equipment departments. My responsibilities include:General Management:I hold weekly production meetings and lead the team that conducts root cause analyses and implements corrective actions for any testing and operational non-conformances.I manage relationships with external vendors and service providers. These include contractors servicing HVAC, plumbing, electrical, and security, plus those servicing for our array of lab equipment. I also identify and recommend new equipment. HR Management: I interview and hire employees, prepare performance reviews, coach employees on career development plans, and implement disciplinary action. Through my efforts we have achieved 93% employee retention.Project Management: I oversee 100+ laboratory projects on an ongoing basis. This includes organizing project timelines and assigning tasks to study directors and the laboratory supervisor. I track daily/weekly progress and report the results to our executive management team.I have also managed installation of new equipment, including conferring with vendors and service technicians.My Key Contributions:>Authoring laboratory SOPs, job aids and processes that improved efficiency, standardized processes, and enhanced quality of lab results.>Developing quality-controlled documentation that decreased technical review times by 82.2% (45-minute write-up and review reduced to 8 minutes).>Introducing a training system that has reduced training time by 66.7% for lab staff and 75% for the technical writing team.>Transitioning from an Excel-based platform to Smartsheet, which facilitated more timely updates to customers.

I began in this role while still maintaining my Facilities Engineer role and continue to serve in this capacity in my current role as Operations Manager.In this role, I develop and monitor testing protocols, collect and review test data, and serve as point-of-contact for clients regarding certification of clients’ medical devices. I perform laboratory tests and train laboratory staff in testing protocols. I also confer with the Quality Department regarding maintenance and updating of laboratory equipment.

I directed all building and equipment maintenance programs to ensure the continuous safe and efficient operation of our physical plant, administrative offices, and laboratory facilities. This included:● Maintaining preventive maintenance schedules for over 900 individual pieces of equipment.● Managing calibration programs for lab equipment, including sterilizers (Steam, EtO Gas, Gas Plasma Hydrogen Peroxide, Chemical Vapor, Dry Heat).● Authoring, implementing, and periodically reviewing standard operating procedures, validation standards, and qualification documentation for laboratory equipment and processes. ● Managing relationships with building maintenance contractors for HVAC systems, security systems, boiler maintenance, facilities maintenance, and water treatment. ● Overseeing qualification and installation of all laboratory equipment to meet ISO quality standards.● Playing an integral role in our transition from ISO 9001 to ISO 17025 quality standards.

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