Careers in MedTech

SUMMARY: This role will direct the development and activities of employees engaged in manufacturing activities including training and supervision. Oversees the manufacture of company products by supervising staff, as well as monitoring workflow and supply.  Works with Operations and other cross-functional peers to ensure that production build schedules are obtained.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:

• Adhere to established production plan by monitoring progress, scheduling personnel, resolving production issues, and reporting results of the process flow, and provide production summaries.
• Ensure on-time delivery of daily, weekly, monthly production requirements and targets.
• Recruit, select, train, and provide company orientation for new production operators. Provide guidance for developing personnel growth opportunities.
• Responsible for reviewing employee performance based on job descriptions to determine competency, knowledge, and contribution. Provide coaching, counseling, and disciplining employees as required. Initiate and enforce production systems, policies, and procedures.
• Provide manufacturing information by compiling, initiating, sorting, and analyzing production data, performance records, and responding to requests.
• Establish workflow by monitoring process steps, and balancing personnel and resource requirements.
• Facilitate corrections to production issues within process controls by fostering a spirit of cooperation within and between cross-functional departments.
• Maintain a positive work environment, ensure compliance with safety and quality standards in accordance with established policies and procedures.
• Ensure continual operation of equipment by coordinating repairs, calibration, PMs, and evaluate new equipment, processes, and techniques.
• Create and revise procedures by analyzing operating practices, record-keeping systems, forms of control, budgets, and personnel requirements to implement change as required.
• Maintain a safe and clean work environment by educating and training personnel on the use of all control points, and equipment to maintain compliance with established policies and procedures.
• Resolve production and personnel problems by investigating the issues, analyzing data, identifying solutions, and recommending an action plan.
• Analyze production methods and implement process and cost improvements.
• Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
• Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.
• Actively promote and support the company’s Management Review process.
• Inform responsible personnel of concerns involving product quality.
• Perform job functions in a safe and effective manner.
• Other duties as assigned

EDUCATION/EXPERIENCE: 

• An AA in a technical or business discipline and a minimum of 8 years of experience in a regulated manufacturing environment or equivalent education and experience, including at least 2 years of previous supervisory experience.
• Knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and applicable Quality Management System (QMS) standards.
• Must be able to work well with others, train mentor and supervise staff, handle multiple tasks effectively, able to organize work, formulate policy, motivate employees, direct activities, multi-task, assess, evaluate and solve problems to meet deadlines.
• Must be detail-oriented and should possess good interpersonal skills to be able to interact and present information between production and cross-functional departments.