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Quality Control Engineering Manager

2 months ago

Feasterville, Pennsylvania, United States Insight Global Full time

Essential Qualifications:

  • Bachelor's Degree in Engineering or a related discipline
  • Proficient in statistical analysis (Minitab)
  • Expertise in monitoring performance and process capabilities (Cpk and PpK)
  • Strong skills in Project Management
  • Experience with documentation, cGMP, and FDA validation methods
  • Minimum of 3 years in a quality-focused manufacturing environment
  • Ability to read and interpret technical engineering documents

Preferred Qualifications:

  • Experience in the medical device or packaging sectors

Responsibilities:

A leading company is seeking a Quality Engineering Project Manager to enhance their team. This role involves supporting the development and execution of validation scopes, including First Article Inspections, IQ/OQ/PQ, and Process Verification. The successful candidate will create project scope statements and proposals while maintaining time study data to assess the progress of quality and validation initiatives.

This position requires frequent interaction with both internal and external stakeholders to ascertain requirements and subsequently develop effective validation protocols. In the event of validation failures, the individual will be tasked with investigating the issues and determining corrective actions. Additionally, this role includes overseeing a small team of quality specialists, emphasizing a strong grasp of manufacturing and quality processes.