Quality Assurance Engineer
Skills
- Strong understanding of quality control principles and testing methodologies
- Experience with statistical analysis and data-driven quality decisions
- Calibration and test equipment experience
- Knowledge of regulatory and quality standards for medical devices (e.g., ISO 13485 / FDA expectations)
- Clear written and verbal communication across teams
- Attention to detail and accurate documentation practices
- Problem solving and root cause analysis
- Ability to develop and deliver training and maintain certification records
Responsibilities
- Develop and implement quality control protocols, inspection plans, and standard operating procedures.
- Perform product and materials testing, analyze test data, document findings, and report nonconformances.
- Work with engineering and manufacturing teams to identify and implement process improvements.
- Maintain comprehensive documentation of quality activities, test results, corrective actions, and calibration records.
- Oversee and manage employee training, certifications, documentation, and records related to quality.
- Create and execute calibration procedures for production and test equipment and maintain calibration logs.
- Ensure compliance with internal quality policies and applicable external regulatory requirements.
- Investigate quality issues, perform root cause analysis, and propose corrective and preventive actions.
Education
- Bachelor’s degree in engineering (required)
- Preferred areas: biomedical, mechanical, electrical engineering or related discipline
Benefits
- Subsidized medical and dental insurance coverage for employees and dependents
- Life insurance, short-term disability, long-term disability
- 401(k)
- Discretionary unlimited PTO (for full-time, exempt employees)
- Flexible Spending Account options
- Commuter benefits (for NY employees)
- Potential discretionary bonuses and/or equity grants subject to board approval
Average salary estimate
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