Quality Systems Engineer
Role details
Job location
Tech stack
Job description
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.
Responsibilities
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Support and enhance global quality assurance systems, including document control, nonconformance management, CAPA, audit management, and training systems.
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Act as a key user or system administrator for QMS platforms, ensuring proper configuration, data integrity, and long-term scalability.
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Collaborate with IT and software vendors to plan and implement system improvements, upgrades, and new functionalities.
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Ensure system workflows reflect future business needs, regulatory expectations, and global quality standards.
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Lead efforts to standardize work processes across all facilities.
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Work with FEM to establish and maintain standard formatting, templates, and structure for controlled documents.
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Define and govern the centralized document control structure.
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Guide facilities through the transition from local variations to standardized global documentation.
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Collaborate and work with the Global Compliance Manager to support the development of proactive audit plans based on future impact orders and risk assessments.
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Ensure quality system records and documentation are audit-ready well in advance of scheduled assessments.
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Identify system gaps that could affect future compliance and develop long-term corrective strategies.
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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).
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Participate in internal audits and support facilities in preparing for external audits.
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Provide guidance and technical support to facility teams on quality tools, documentation, and best practices.
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Partner with Operations, Engineering, Training, and other functions to ensure quality system requirements are understood and consistently applied.
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Support cross-functional initiatives requiring alignment of processes, documentation, or system workflows.
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Facilitate communication between global quality leadership and site-level teams.
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Develop, revise, and standardize quality system procedures, work instructions, and forms.
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Ensure documentation meets internal requirements and external regulatory standards.
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Support training and rollout of new or updated procedures and system functionalities.
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Identify opportunities to improve system efficiency, usability, and long-term sustainability.
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Analyze system data to identify trends, gaps, or improvement opportunities.
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Lead or support continuous improvement initiatives related to digital quality tools and documentation processes.
Requirements
Do you have experience in Analytics?, * Bachelor's degree in an Engineering discipline, or a related technical field.
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Experience working with quality management systems or enterprise quality software.
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Strong understanding of quality assurance principles, documentation control, and compliance requirements.
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Strong analytical, organizational, and communication skills.
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Experience with continuous improvement methodologies. Preferred Attributes
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Forward-thinking mindset with the ability to anticipate future system needs.
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Detail-oriented with strong problem-solving and planning skills.
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Comfortable working in a dynamic environment with evolving system requirements.
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Proactive, collaborative, and committed to driving long-term system improvements.
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Able to work independently.