Implements and manages a staffing plan by identifying resources requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
Develops direct reports by securing appropriate training, assigning progressively challenging tasks, rewarding positive behavior, and applying disciplinary action as appropriate.
Trains and certifies to all critical assembly operations and understands all line PFM s.
Monitors daily metrics and provides direction and guidance to lower level supervisors, or skilled nonexempt staff to achieve unit or Project goals.
Retains responsibility for product from initial assembly to final distribution. Schedules and organizes assigned manufacturing lines to achieve 100% product availability and maintain targets levels of inventories.
Communicates to line personnel daily while maintaining a constant line presence.
Maintains regular communication with exempt level staff to ensure alignment in running operations and achieving objectives.
Maintains a safe environment with 100% training and compliance with applicable procedures.
Responsible for achieving dept. attendance targets including immediate feedback to employee by instance.
Coordinates activities related to shift starts and changes.
Communicate with other departments and functions as need in support of meeting operational objectives.
Helps develop, interpret and execute policies that affect work processes and personnel with the assigned organizational unit.
Oversees personnel and processes to ensure full compliance with internal and external regulations.
Monitors and communicates internal and external indicators that impact the business and or industry by reviewing reports and newletters, reading organizational literature, meeting with peers and reading development reports.
Bachelor’s Degree in Engineering / Business or related career.
5-7 years of related work experience
Influence and Leadership.
Knowledge of applicable regulations and standards affecting the manufacture of Medical Devices (i.e., cGMPs and CFRs).
Accountable to ensure the operation team manufactures products that meet the highest standards in quality, customer service, and compliance with regulatory agencies.
Error in judgment or execution could result in serious quality issues, interruption in product availability, have a direct effect on patients' lives, and generate significant manufacturing cost variances and inventory issues.
Accountable to ensure that safety, quality and performance goals are met on a daily and weekly basis.
Error in judgment may interrupt weekly production goals as well as jeopardize product availability.
Fully Bilingual (English and Spanish) / Required.
Preferred Qualifications & Education
Industry / supervisory experience and direct exposure to Operations desired.
Ability to direct activities of employees. Ability to train and motivate assigned personnel.
Ability to continuously improve upon safety, quality, and performance.
Has understanding of operations standards and documentation.
Has understanding of safety, quality, and performance goals and has the ability to execute on goals.
Must be able to lead and motivate people to ensure safety, quality and performance.
Ability to make decisions with sound judgment and execute on such decisions with quantifiable results.
Ability to make difficult decisions within a time-sensitive environment.
Ability to find solutions to difficult problems and / or the ability to find resources to solve such problems. Able to confront and resolve conflict and lead efforts to resolve critical situations.
Uses good judgment to make sound decisions. This position requires a high level of adaptability, flexibility, clear direction and creative decision-making in a highly challenging environment.