Production Manager, Post Sterilization Services

Cook Medical; Ellettsville (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Cook Incorporated in Ellettsville, IN seeks a Production Manager for Post Sterilization Services. The role oversees multiple manufacturing departments, ensuring resources align with delivery goals and adherence to internal and external standards.

Regular interaction with Operations Management supports the global business direction and identifies improvement opportunities. The position emphasizes leadership, regulatory compliance, and continuous improvement, with a focus on safety, quality, and

Qualifications

• High school diploma or GED required.
• Bachelor's degree in engineering, management or related field preferred.
• Minimum 2 years experience in manufacturing management preferred.
• Knowledge of ISO, GMP and CFR standards.
• Proficiency with Microsoft Word and Excel.

Responsibilities

• Maintain familiarity with the state of the department(s) by spending time in the work areas.
• Ensure work orders are updated in a timely manner.
• Maintain and evaluate KPIs for productivity and performance.
• Identify and develop natural leaders within the team.
• Handle personnel matters including performance issues and development plans.
• Drive quality and efficiency improvements across operations.
• Provide direction to ensure clear expectations and goals are understood by staff.
• Maintain a safe, sanitary and orderly production environment.
• Support audits, investigations and tours in the department.
• Ensure adherence to internal procedures and regulatory requirements (FDA CFR 820, ISO 13485).
• Initiate actions to improve quality and efficiency.

Skills

Manufacturing management

Leadership

Quality & regulatory knowledge

Education

High School Diploma or GED

Bachelor's degree in Engineering, Management or related field

Tools

Microsoft Word

Microsoft Excel

Job description

Production Manager, Post Sterilization Services

Overview

The Production Manager at Cook Incorporated establishes directions and goals within one or more manufacturing departments and ensures conformance/compliance to internal procedures and external standards; and ensures adequate resources are available to meet delivery standards for internal and external products. This position interacts regularly with Operations Management to support global business direction & identify areas in need of improvement.

Responsibilities

• Maintain first-hand understanding of the state of the department(s) by spending an effective amount of time in the department(s)
• Ensure work order status is updated in a timely manner
• Maintain and evaluate KPI’s for productivity and evaluations
• Recognize, develop and utilize natural leaders
• Must be heavily involved with all personnel matters including employee performance issues, corrective action processes, and employee development plans and actions
• Drive quality and efficiency improvements
• Provide direction/guidance to ensure that expectations and goals are clear and understood
• Ensure work is being completed in a safe, sanitary and orderly environment
• Ensure area functions effectively independent of leadership oversight
• Support audits, investigations and tours within the department
• Ensure compliance of, and adherence to, internal procedures and processes
• Initiate actions to improve quality and efficiency
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements

Qualifications

• High School Diploma or GED required
• Bachelors degree in Engineering, Management or a related field; or experience of such kind and amount as to provide a comparable background preferred
• Minimum 2 years experience in manufacturing management preferred
• Knowledge of/or training in ISO, GMP and CFR standards
• Computer proficiency, experience with Microsoft products (Word and Excel)

Physical Requirements:

• General office setting.
• Exposure to moderate noise and light levels within manufacturing facility
• Requires close visual acuity when working with computers, etc.
• Maintain a physical presence in the area of responsibility
• Proper attire/clothing and personal protective equipment/clothing as required within Controlled Production Areas

“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.