Operations Manager

Join a Team That is Revolutionizing Medical Device Packaging As we grow our team, we are always looking for dynamic individuals who share our enthusiasm for creating impactful change and exceeding expectations Interested in taking up the shield and providing innovative packaging solutions and services to protect our customer's medical devices? Guardian Medical, USA is a small company that specializes in creating advanced packaging solutions for medical devices. We design, develop, manufacture, and distribute sterile packaging and packaging services to ensure the safety and sterility of medical devices and implants. Our focus on innovation allows us to offer unique and efficient sterile packaging solutions to the medical industry. Our employees are the true Guardians of our customer's medical devices, ensuring their safe and sterile journey to the surgical field. With our united efforts and shared values, we are revolutionizing medical device packaging. If you are interested in taking up the shield and providing innovative packaging solutions and services to protect our customer's medical devices, please submit your application or resume for the open Operations Manager position! Benefits We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees, including: Eight (8) paid holidays annually Paid sick leave Paid vacation time Medical, dental, and vision insurance Employer-paid basic life insurance Employer-paid short-term and long-term disability insurance Company contributions to a 401(k)-retirement plan Employer-funded Health Savings Account (HSA) contributions each pay period Unpaid Emergency Leave Time Overview The Operations Manager is responsible for overseeing daily operations within a regulated medical device manufacturing and contract packaging environment ensuring efficiency, productivity and exceptional customer service. This role provides leadership and direction across operational activities, ensuring the successful onboarding of new customers, effective execution of new product development projects, and continuous improvement of processes that support company growth and profitability, while working within the Quality System to ensure quality excellence and regulatory compliance. Essential Job Duties and Responsibilities Customer Service Manage relationships with customer purchasing and procurement contacts to ensure effective communication and customer satisfaction Develop and implement operational plans to ensure customer requirements are met accurately, timely and with a high level of responsiveness Maintain strong customer relationships through proactive communication and responsiveness to customer inquiries and concerns Coordinate with CTO and Sales engineer to review new customer requirements, specifications, packaging needs, and service expectations to ensure operational readiness Utilize CRM platform to organize and prioritize new product launch projects for existing customers Support Guardian’s Engineering Manager and engineers to expedite customer onboarding, validation and development activity Operational Management Develop, implement and monitor day-to-day operational systems and processes to provide visibility into the goals, progress and results for the team and for management Manage and support the Production Supervisor and Purchasing Lead to establish order prioritization, inventory levels and shipment planning to meet customers’ requirements and timelines Devise and execute strategies to grow the operations and implement process improvements to maximize output and minimize costs through the management of budgets, strategic forecasting and regular reporting Manage supplier relationships and coordinate new product/inventory item launches Manage and support Guardian’s Customer Service/Purchasing Lead to negotiate quotes, process orders, utilize the ERP system for inventory management and controlled purchasing and receiving operations in alignment with the QMS requirements, issuing and monitoring purchase orders to vendors Ensure compliance with OSHA and company safety requirements Investigate incidents and implement corrective actions to prevent recurrence Champion operation’s adherence to Guardian’s Quality Management System while providing feedback to the quality team regarding process improvements Promote a culture of quality and continuous improvement throughout the company Leadership & Team Development Collaborate regularly with Human Resources, Supervisor(s), Lead(s) to grow and lead the team, proliferate Guardian’s culture to engage and maintain a stable and motivated team, and to establish and maintain a trusting, inclusive and productive work environment Lead, coach and develop supervisors, project engineers and production personnel Establish clear performance expectations and conduct regular performance evaluations Identify training needs and implement employee development programs Other duties as assigned Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. General Must be authorized to work in the U.S. on a full-time, long-term basis Able to read, comprehend, and speak English fluently to communicate questions, errors and production needs effectively, concisely and clearly Knowledge / Education / Skills/ Experience Bachelor’s degree in Business Administration, Operations Management, Bioengineering or related technical discipline 5+ years of operations management experience in a manufacturing environment Experience within a sterile barrier and/or medical device manufacturing, packaging industry is strongly preferred Proven experience managing teams, production planning, quality systems and continuous improvement/lean manufacturing initiatives Knowledge of ISO 13485-aligned practices, FDA expectations, document control and change control is preferred Demonstration of effective communication, both verbally and in writing, with diverse audiences, including customers, employees, executive leadership and auditors Experience with ERP and inventory management systems Proficiency in Microsoft Office applications Able to analyze operational data and make informed business decisions Strong project management and organizational skills Mental/Emotional Abilities Positive interpersonal skills and professional interactions with customers, vendors, coworkers and employees through adaptability, self-reflection and good judgement Able to remain calm, professional and effective when managing conflict, customer concerns, production challenges or unexpected operational disruptions Strong organizational and time management skills with the ability to work independently and make decisions with minimal supervision Physical Abilities Able to walk throughout the production facility and warehouse areas Able to travel to partner facilities, customer and vendor plants Able to lift up to 20 pounds Must be willing and able to work in a cleanroom environment to monitor production and/or project assignments Able to sit for long periods of time while working on a computer and/or attending in-person and/or online meetings Special Notes Smoking and/or vaping are not conducive to a cleanroom environment nor are the remnants of smoking/vaping particles on an individual. Therefore, Guardian has specific guidelines regarding an individual’s smoking/vaping habits. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Working Conditions Indoor facility located next to an active commercial and military airport Air quality-controlled rooms that have strict entry protocol including the use of gowns, masks, gloves and hair nets Climate-controlled and clean office space, production area and warehouse with very low noise level Sedentary work with extended periods of computer use; alternate between sitting and standing positions On-site position with some travel to attend conferences, visit customer and/or vendor facilities and to participate in training Disclaimer: This position description is used as a basis for determining the position classification and is maintained as an official record of the duties assigned to this position. This description is intended to be an accurate reflection of the assigned work; however, it is understood that duties may be removed, modified or assigned, and may not be included in this description. Contact us today to see how we can make a difference in your operations. #J-18808-Ljbffr Guardian Medical USA Inc.