Quality Systems Engineer

Quality Systems Engineer Job Description

The Quality Systems Engineer is responsible for ensuring an efficient/compliant Quality Management System (QMS), including analysis, development and revision of QMS processes, performance monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards.

• Takes ownership of Quality processes including Audits, Document Control, Training, CAPA etc. ensuring that QMS is efficient and meets the regulatory requirements.
• Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
• Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring they are accurate, clear, and compliant with relevant standards.
• Conducts risk assessment activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.
• Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
• Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
• Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
• Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
• Leads cross‑functional problem‑solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
• Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and providing responses to audit findings in collaboration with stakeholders.

• You have a minimum of 5+ years’ experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments, focusing on QMS compliance, documenting QMS changes, gap assessments, audits, document control, training, CAPAs, etc.
• You have experience managing/maintaining training metrics and matrix.
• You have proven experience leading cross‑functional teams and mentoring less experienced engineers.
• You have detailed experience and knowledge in CAPA processes, including problem identification, root cause analysis and tools, and implementation of solutions to prevent recurrence and drive continuous improvement.
• You’re experienced in data analysis, understanding QMS metrics and KPIs, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
• You’re able to build and cultivate relationships with supervisors, functional peer groups, stakeholders, and suppliers.
• You have a minimum of a bachelor’s degree (required) in quality, engineering or similar disciplines. ASQ‑CQE, ISO Lead Auditor certifications desired.
• You must be able to successfully perform the following minimum physical, cognitive and environmental job requirements with or without accommodation for this position.

We believe that we are better together than a part. For our office‑based teams, this means working in‑person at least 3 days per week.
Onsite roles require full‑time (5 days per week) presence in the company’s facilities. Field roles are most effectively done outside the company’s main facilities, generally at customer or supplier locations.
This is an ON‑SITE role.

We are a health‑technology company. We built our entire company around the belief that every human matters, and we won’t stop until everybody everywhere has access to…