Production Lead

Department: 
Production

Overview

We are looking for a talented individual to join our dynamic Keystone Manufacturing team located in Kalamazoo, MI.   A Production Lead is a motivated, self-starter who provides oversight and guidance in production work cells. 

The Production Lead will also effectively follow Keystone’s SOPs to assemble and package products on time while ensuring specifications are met and maintaining the production environment.  The lead will complete visual inspections, and other testing as required, to identify non-conformities in parallel with production.

A successful Production Lead must be capable of working with minimal supervision, have a “can do” attitude, possess creative problem-solving skills and be willing to do “whatever it takes” to complete assigned tasks efficiently and effectively.  This team member should have excellent interpersonal skills, great attention to detail and be highly organized with the ability to multi task with minimum interruption to work progress.

 Responsibilities and Activities  

  • Provides guidance and oversight for all production associates working in a given manufacturing cell of responsibility
  • Responsible for manufacture and assembly of medical devices according to Keystone Standard Operating Procedures (SOP)
  • Responsible for following all established policies, practices and procedures related to all job duties
  • Responsible for following all Good Documentation Practices (GDP), Good Manufacturing Practices (GMP) and SOPs as defined by Keystone’s policies, practices and procedures to ensure that FDA regulations, ISO Standards and Keystone quality standards are met
  • Prepare work area and keep it safe, clean and organized per Keystone standards
  • Generate product label per specification to support Keystone production needs
  • Verify accuracy of product produced against specification and resolve discrepancies as directed by Keystone standards
  • Use measuring and testing devices according to established instructions or quality practice standards
  • Use manufacturing and quality assurance specifications to determine acceptance and/or performance on all assemblies

 

 Minimum Requirements and Qualifications

  • High school diploma or equivalent
  • 3+ years’ experience working in a regulated manufacturing environment
  • Experience leading a team of 4+ individuals.
  • Excellent communication and attention to detail.
  • Strong organization skills and ability to handle multiple assignments simultaneously.
  • Proven computer aptitude (word processing, spreadsheets, database)
  • Must be able to routinely make decisions that immediately impact operations.
  • Must be able to understand and execute tasks per Standard Operating Procedures and Customer Specifications.
  • Must have the ability to operate hand tools, inspection equipment, and common office equipment.
  • Must have the ability to operate in a fast-paced environment, sometimes requiring extended work hours, including evenings and weekends as necessary, to ensure minimal interruption to production.
  • Must have excellent interpersonal communications skills to ensure core corporate values are demonstrated and promoted to all coworkers.
  • Must have excellent documentation and organizational skills.
  • Experience with sterile barrier packaging is a plus.
  • Experience working in a clean room is a plus.
  • Experience with single use disposable medical devices is a plus.
  • Experience with seal integrity and seal strength testing is a plus.
  • References must be provided upon request.
  • Authorized to work in the US without sponsorship.

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