Senior Quality Engineer, Integrated Systems

West

Exton, PA, US
On-site
Quality management system best practices
Regulatory and quality compliance
Product development lifecycle
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week

Job Summary

  • This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.
  • In this role, you will provide quality direction, governance, and Quality Management System best practices across the programs you support.
  • West offers a generous PTO, inclusive & collaborative culture, global career opportunities, and recognition & rewards.

Matching Summary

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.

Skills & Requirements

Must-have

  • Quality Management System best practices
  • Regulatory and quality compliance
  • Product development lifecycle
  • cGMP requirements
  • ISO 17025 certification efforts
  • Risk and hazard analysis
  • QMS activities (CAPA, Failure Investigation)

Nice-to-have

  • Inclusive approach to project planning
  • Continuous improvement of products, services, and processes
  • Adaptable to changes in the work environment
  • High attention to detail and accuracy

Key Requirements

  • Bachelor's Degree in Engineering or Science or equivalent experience
  • Minimum 5 years of experience in a regulated industry
  • 4+ years of experience defining, planning, and executing projects
  • In-depth knowledge of cGMP, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971
  • Proficiency in standard project management tools and software
  • Proficiency in statistical software, Windows OS, Microsoft Office Suite

Work Rights

Not specified

Tailored Resume

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