Description
We are hiring on behalf of our client for a Quality Engineer to support and drive product and process quality initiatives within a regulated manufacturing environment.
This role is critical in ensuring product safety, compliance, and performance across the full lifecycle—from design transfer through post-market activities. The ideal candidate brings strong analytical skills, hands-on experience with quality systems, and the ability to lead cross-functional investigations and improvement initiatives.
Position Overview
The Quality Engineer will play a key role in monitoring product quality, leading root cause investigations, and implementing corrective actions to drive continuous improvement.
This position partners closely with engineering, manufacturing, and quality teams to ensure compliance with regulatory standards and internal quality management systems.
Key Responsibilities
- Develop, monitor, and report on product quality metrics, including complaint rate tracking and trending
- Establish processes for monitoring and triggering investigations into product and process quality issues
- Lead and support root cause investigations using structured problem-solving methodologies
- Define and drive annual quality improvement targets (e.g., complaint reduction initiatives)
- Provide expertise in quality tools such as statistical sampling, DOE, and root cause analysis
- Ensure validation processes support product safety, efficacy, and regulatory compliance
- Support Design Transfer and Product Transfer activities, including PFMEA and supplier collaboration
- Investigate and resolve field-related product quality issues
- Lead or support CAPA activities, including effectiveness verification
- Conduct internal audits and support audit readiness efforts
- Ensure proper control and documentation of equipment, tooling, calibration, and maintenance
- Manage product and process changes in compliance with QMS, FDA regulations, and applicable standards
- Lead product quality improvement projects and present findings to cross-functional teams and leadership
- Review engineering change requests to ensure alignment with quality, manufacturability, and regulatory requirements
- Identify and implement continuous improvement opportunities
- Manage multiple priorities effectively in a deadline-driven environment
Required Qualifications
- Bachelor’s degree in Engineering or a related technical field
- 5+ years of experience in a product quality role within a regulated industry (medical device preferred)
- Proven experience resolving product quality issues within cross-functional, matrixed environments
- Demonstrated ability to lead quality initiatives and collaborate across teams
Technical Skills & Knowledge
- Strong knowledge of ISO 13485 and working knowledge of FDA Quality System Regulations (QSR)
- Experience with risk management standards (e.g., ISO 14971) and FMEA methodologies
- Expertise in root cause analysis tools and structured problem-solving techniques
- Working knowledge of CAPA processes and internal auditing
- Familiarity with PLM systems (e.g., Oracle or similar) and engineering documentation
- Experience with 3D modeling tools (e.g., SolidWorks) is a plus
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)
- Understanding of project management principles