Department: Quality Assurance


Why This Opportunity Stands Out
Join a company operating at the cutting edge of the medical device industry, developing
advanced technologies used in surgical and clinical environments. Their products combine
precision engineering with innovative energy-based applications that support physicians
and improve patient outcomes.

This role offers high visibility across engineering, operations, and regulatory teams, with the
opportunity to directly influence product quality, reliability, and compliance in a highly
regulated space. If you’re motivated by meaningful work and continuous improvement, this
is a strong platform for growth.

Job Summary
The Sustaining Quality Engineer is responsible for maintaining the quality, compliance, and
performance of post-market medical device products and their associated manufacturing
processes. This role ensures adherence to regulatory standards while supporting
validation, change management, and continuous improvement initiatives across
production.

Responsibilities
• Support change management activities to ensure compliant and timely
implementation of product and process updates
• Maintain and update technical documentation, including specifications,
validations, and quality records
• Ensure manufacturing processes consistently meet product specifications and
regulatory requirements
• Own and manage validation programs, including IQ/OQ/PQ and revalidation
activities
• Monitor production quality and drive improvements in process performance and
consistency
• Analyze data to evaluate trends, process capability, and risk
• Develop and maintain statistical process controls and sampling plans
• Create and execute test methods to support product enhancements and
component changes
• Lead or support non-conformance investigations, root cause analysis, and CAPA
activities
• Partner cross-functionally to drive continuous improvement across manufacturing
and quality systems
• Ensure compliance with applicable medical device regulations and standards

Qualifications
• Bachelor’s degree in Engineering or related technical field
• 3–5+ years of experience in medical device quality, manufacturing, or
engineering
• Experience supporting validation activities (IQ/OQ/PQ) and test method
development
• Strong understanding of quality systems and change control in regulated
environments
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and global regulatory frameworks
• Proficiency in statistical analysis and quality tools (e.g., Minitab or equivalent)
• Experience with root cause analysis, CAPA, and risk management methodologies
(e.g., FMEA)
Key Strengths
• Analytical and data-driven problem solver
• Strong communicator able to simplify complex technical and regulatory concepts
• Detail-oriented with a strong focus on compliance and documentation accuracy
• Collaborative across cross-functional teams
• Adaptable in a fast-paced, regulated manufacturing environment