This Senior Quality Engineer role serves as a key quality partner supporting product development, supplier quality, risk management, and Quality Management System execution within a growing medical device organization. This position is highly hands-on, supporting R&D activities, investigating product failures, collaborating with manufacturing partners, and acting as a strategic right-hand resource to Quality leadership.
Client Details
Our client is a medical device innovator develops precision-engineered technologies that improve patient and caregiver experiences in vascular access procedures. With multiple recent regulatory approvals and an expanding product pipeline, the organization is building momentum while maintaining the agility and visibility of a startup environment.
Description
This Senior Quality Engineer will be responsible for:
- Supporting and improving the Quality Management System (QMS)
- Partnering with R&D on design controls and product development activities
- Leading risk management activities in compliance with ISO 14971
- Investigating nonconformances, complaints, and CAPAs
- Managing supplier qualification, monitoring, and quality performance
- Conducting root cause investigations and product failure analysis
- Supporting process validation and manufacturing transfer activities
- Reviewing engineering changes for quality and regulatory impact
- Monitoring quality metrics and driving continuous improvement initiatives
- Supporting contract manufacturing operations and supplier relationships
- Assisting with internal audits, supplier audits, and inspection readiness
- Serving as a key quality resource for engineering and manufacturing teams
Profile
A Successful Senior Quality Engineer will have:
- 7+ years of medical device industry experience.
- 5+ years in Quality Engineering or Quality Assurance roles.
- Strong knowledge of ISO 13485, ISO 14971, FDA/QSR requirements, and medical device regulations.
- Experience with supplier qualification, supplier audits, and supplier quality management.
- Experience supporting CAPA, complaint handling, risk management, and nonconformance investigations.
- Hands-on validation experience including IQ/OQ/PQ and process validation.
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- Experience in Class II medical devices; startup experience is highly desirable.
Job Offer
- Bonus opportunity based on level.
- Potential equity participation
- Direct exposure to executive leadership and company growth.
- 15 days PTO plus 7 paid holidays.
- Medical, dental, and vision coverage.
- 401(k) plan with future company match under consideration.
Apply today to be considered within 24 hours!
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