Sr. Engineer- Design Quality
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Key skills for this role
Role Overview
The Design Quality Engineer represents the quality organization on medical device development projects.
The role ensures compliance with QMS and design control processes, maintains quality records, and supports successful design transfer to manufacturing.
Key Skills for This Role
Full Job Posting
Role overview
The Design Quality Engineer represents the quality organization on medical device development projects.
The role ensures compliance with QMS and design control processes, maintains quality records, and supports successful design transfer to manufacturing.
Essential duties
- Support product design changes and new product development projects.
- Ensure compliance with QMS and design control processes and procedures.
- Review and approve product release documentation and document changes.
- Review technical files, clinical data, risk management files, and traceability reports.
- Confirm development evidence is filed in the Design History File.
- Perform Design History File audits and data integrity audits.
- Create draft risk management documentation and analyze post-market data.
- Review and approve protocols, testing, experiments, analyses, and design verification and validation reports.
Experience and education
- Five to twelve years of experience within a regulated industry is required.
- Medical or pharmaceutical experience is preferred.
- A bachelor's degree or equivalent education and experience may be considered.
- A Bachelor of Science degree in Engineering is preferred.
Required skills
- Fluent spoken and written English is required.
- Planning, prioritization, communication, teamwork, and effective use of PC software are required.
- The role requires understanding product design and process development for assigned projects.
- Knowledge of protocols, statistical tools, and ISO standards is preferred or desired.
Additional responsibilities
Work may include developing engineering skills and breadth through assigned projects.
Additional projects may be assigned as needed.
The role may work with manufacturing and other functions on manufacturing and regulatory compliance issues.
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