Quality Systems Engineer

VictaulicEaston, PA
Onsite

About The Position

Quality Systems Engineer plays a strategic role in developing, maintaining, and advancing the organization’s global Quality Assurance Systems. This position emphasizes future planning, system optimization, and long-term quality infrastructure development rather than day-to-day issue response. The role partners with cross-functional teams to ensure quality processes, documentation, and system controls are standardized, scalable, and aligned across all facilities. A key focus is establishing consistent documentation practices, driving system improvements, and supporting audit readiness based on future impact orders and organizational priorities.

Requirements

  • Bachelor’s degree in an Engineering discipline, or a related technical field.
  • Experience working with quality management systems or enterprise quality software.
  • Strong understanding of quality assurance principles, documentation control, and compliance requirements.
  • Strong analytical, organizational, and communication skills.
  • Experience with continuous improvement methodologies.

Nice To Haves

  • Forward-thinking mindset with the ability to anticipate future system needs.
  • Detail-oriented with strong problem-solving and planning skills.
  • Comfortable working in a dynamic environment with evolving system requirements.
  • Proactive, collaborative, and committed to driving long-term system improvements.
  • Able to work independently.

Responsibilities

  • Support and enhance global quality assurance systems, including document control, nonconformance management, CAPA, audit management, and training systems.
  • Act as a key user or system administrator for QMS platforms, ensuring proper configuration, data integrity, and long-term scalability.
  • Collaborate with IT and software vendors to plan and implement system improvements, upgrades, and new functionalities.
  • Ensure system workflows reflect future business needs, regulatory expectations, and global quality standards.
  • Lead efforts to standardize work processes across all facilities.
  • Work with FEM to establish and maintain standard formatting, templates, and structure for controlled documents.
  • Define and govern the centralized document control structure.
  • Guide facilities through the transition from local variations to standardized global documentation.
  • Collaborate and work with the Global Compliance Manager to support the development of proactive audit plans based on future impact orders and risk assessments.
  • Ensure quality system records and documentation are audit-ready well in advance of scheduled assessments.
  • Identify system gaps that could affect future compliance and develop long-term corrective strategies.
  • Provide data and insights to global quality leadership to support strategic planning.
  • Collaborate with and assist the Global Compliance Manager in maintaining compliance with internal standards and external regulatory requirements (e.g., ISO 9001 or industry-specific standards).
  • Participate in internal audits and support facilities in preparing for external audits.
  • Provide guidance and technical support to facility teams on quality tools, documentation, and best practices.
  • Partner with Operations, Engineering, Training, and other functions to ensure quality system requirements are understood and consistently applied.
  • Support cross-functional initiatives requiring alignment of processes, documentation, or system workflows.
  • Facilitate communication between global quality leadership and site-level teams.
  • Develop, revise, and standardize quality system procedures, work instructions, and forms.
  • Ensure documentation meets internal requirements and external regulatory standards.
  • Support training and rollout of new or updated procedures and system functionalities.
  • Identify opportunities to improve system efficiency, usability, and long-term sustainability.
  • Analyze system data to identify trends, gaps, or improvement opportunities.
  • Lead or support continuous improvement initiatives related to digital quality tools and documentation processes.
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