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AIME USA is the leading fully American made surgical mask company that is based in Dade City, Florida. Passionate about meeting the serious need for available quality masks to the United States at the start of the Covid 19 Pandemic- AIME USA started. Through a combination of automation, vertical integration and American grit, AIME USA offers masks competitively priced to international suppliers with higher quality protection, so that American's don't have to choose between Made-in-America excellence and price. With strategic plans and product expansions that will keep the company growing long past the end of the Covid 19 crisis, we are looking for a Sr. Manufacturing Supervisor to join our team as we take our next steps.

The ideal candidate will have a passion for the customers we serve and pride in our 100% American made masks. We are looking for an ambitious individual that would enjoy the fast pace of the start up environment and working with a range of responsibilities. This candidate should be experienced working in a highly regulated industry in a manufacturing setting. Having experience in Good Manufacturing Practices (GMP) and lean manufacturing this individual will help guide the team to the next level. The candidate will have management experience and navigate leading our manufacturing team of operators and mechanics to ensure quality and maximize productivity.

Responsibilities may include the following and other duties may be assigned

Develops and maintain knowledge of products, equipment, processes, regulatory requirements, and safety regulations.
Drives a culture of Safety and Quality.
Responsible for overseeing day to day production goals, quality, and cost objectives.
Manages manufacturing employees and mechanics.
Maintains high level of visibility with production staff. Uses hands-on approach to communicate daily and involve production staff in problem solving.
Aids in the development of new manufacturing and quality documents that meet regulatory requirements.
Makes budgetary recommendations on capital expenditures and labor needs.
Develops schedules and direct labor requirements.
Ensures safety of employees by proactively identifying safety concerns and resolving open incidents in a timely manner.
Accountable for implementing and executing to GMP (good manufacturing practices) with direct reports.
Follows lean manufacturing principles to map out current state processes and develop improvements.
Actively promotes a positive environment that is focused on quality, compliance, and employee development.
Promotes a team atmosphere of trust and mutual respect that embraces diversity.
Procures or develops solid preventative maintenance, calibration, and parts ordering systems.
Gathers, organizes, and interprets data to identify capacity, trends, constraints and waste. Recommends areas of focus and solutions.
Aids in the creation of visual standards and standard work. Sets expectations for operators during daily meetings.

Expected Position Results:

Key manufacturing goals and metrics are achieved consistently.
Waste reduction.
Cost and lead time reduction.
Compliance to safety and housekeeping standards/expectations to prevent employee injuries and/or health hazards.
Fully trained, engaged, enthusiastic, and accountable operators.
Fully developed preventative maintenance, calibration, and parts ordering system.
Standard quality and standard work documentation.

Must Have: Minimum Requirements

Bachelor’s Degree in Engineering, Operations, Business, or related field.
Minimum of 3 years of supervisory experience.
Minimum of 6 years experience in highly regulated manufacturing position.
Personal computer skills in a variety of software programs such as MS Outlook, Word, Excel, PowerPoint, and Visio, inventory management system, and MES (manufacturing execution systems) that support the manufacturing environment.

Nice to Have

Master’s Degree in Engineering, Operations, Business, or related field.
Minimum of 5 years of supervisory experience.
Minimum of 8 years experience in highly regulated manufacturing position.
Class II Medical device manufacturing experience.
Start Up Company experience.
Management of 30+ employees.
Track record of quickly building trust and repour with direct labor.
Demonstrated ability to translate requests of management to achievable actions for operators.
Ability to interact with employees in all levels in a professional, engaging, professional and constructive manner.
Good organizational and visual management skills.
Project Management certification (PMP) or experience.
Lean Sigma Green Belt certification or higher.
FDA 21 CFR 820, ISO 9000 and ISO 13485 experience.
Assembly automation experience.
Understands Statistical Process Control.
Demonstrated ability to transform a workflow to a fully mature, efficient and lean operation.
Previous involvement in high volume, low mix production.
Experience working in automation.
Led Corrective and Preventative Action plans (CAPA).

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