Quality Engineer (Test Method Validation)
About The Position
Ensures compliance with applicable standards and regulatory requirements (e.g., FDA, ISO). Leads laboratory-based quality activities, including hand on experience with Test Method Validation (TMV), Design Verification (DV), and product testing. Authors, executes, and reviews test plans protocols, and reports to support product development. Executes hands-on laboratory testing, data analysis, and technical investigations. Collaborates with Design Engineering, Regulatory, and Laboratory staff to ensure testing activities are appropriately planned, executed, and documented. Supports design controls, risk management, and other quality activities as needed.
Requirements
- Bachelor’s or Master’s degree in Engineering, Science or related field
- 2-4 years of experience in QC, laboratory, or quality departments within medical device or pharmaceutical industries
- Working knowledge of relevant regulations and industry standards (FDA 21 CFR 820, ISO 13485, etc.)
- Proven experience authoring and executing TMV and DV documentation
- Strong hands-on laboratory testing and data analysis experience
- Strong technical writing and documentation skills
- Experience with statistical analysis tools such as Minitab, JMP, or equivalent.
- Self-motivated with good communication and organization skills
Responsibilities
- Author, review, and execute TMV protocols and reports
- Develop and execute Design Verification plans, protocols, and reports
- Support hands-on verification and validation testing activities
- Analyze test data, document results, and communicate findings to project teams
- Investigate test failures, deviations, and nonconformances; support root cause analysis and corrective actions
- Ensure accuracy, completeness, and traceability of testing and validation documentation
- Review and approve quality and testing documentation in accordance with development procedures
- Support project teams and laboratory on quality-related activities
- Provide support for other quality activities, including design controls and risk management documentation
Benefits
- Referral Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
