WHO WE ARE

As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

• Ensure compliance with FDA 21 CFR 820 210:211, ISO 13485, and ISO 14971.
• Review specifications and ensure adherence to material and process requirements.
• Oversee validation and verification of manufacturing processes and equipment.
• Manage documentation for change management and non-conformance reports.
• Lead investigations and root cause analysis of non-conformances.
• Author tech reports, CAPAs, compliant investigations, and validations.
• Work with suppliers to meet quality requirements.
• Support customer complaint management.
• Troubleshoot manufacturing and field issues.
• Analyze quality data and trends; identify improvement areas.
• Champion continuous improvement initiatives.
• Mentor junior quality engineers.
• Collaborate with cross-functional teams.
  Who You Are (Basic Qualifications):
  Bachelor’s degree or equivalent experience
  Minimum of 4 years of quality-related experience in a medical manufacturing environment
  Experience working in a regulated environment
  Knowledge of automated assembly and test procedures
  Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485
  Experience working with an ERP system (SAP)
  Strong data analysis skills
  Strong technical writing and problem-solving skills
  Experience in packaging, serialization, sterilization, and complaint handling
  Experience with updating the test procedures in testing equipment