Principal Quality Systems Specialist
3 days ago
Merit Medical Systems creates innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. We are making a difference in the lives of patients around the world.
Job SummaryThis position provides quality engineering support for products and processes while completing projects in broad areas of assignment supporting design transfer activities. Ensures that the products are designed, tested, and manufactured in compliance with all applicable agency/internal quality requirements and optimizing quality systems and documentation.
Main Responsibilities- Participates in design and development activities assuring the design requirements are appropriately transferred into manufacturing.
- Guides the design team as subject matter expert of Design Control from Design Inputs through Design Outputs, Process Validation, Test Method Validation and Device Master Record creation.
- Coordinates risk analysis/management activities including leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvements.
- Bachelor's Degree in Engineering or related field.
- 15 years of engineering experience.
- Demonstrated working knowledge of 21 CFR 820, ISO 13485, ISO14791, and other medical device related standards.
- Statistical methodologies, quality control and manufacturing tools experience.
- Knowledge of regulatory agency regulations.
- A competitive annual salary range of $130,000-$200,000.
- Flexible shift options: Days, Swing (Eve), and Nights.
- Comprehensive insurance coverage from day one.
- Ongoing training and professional development opportunities.
- A supportive and inclusive work environment.
- The opportunity to contribute to life-changing innovations.
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