Design Quality Engineer

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• Evaluate verification and validation protocols and reports to ensure compliance to external standards and internal standards & procedures
• Provide expertise in risk management and analysis techniques when facilitating completion of risk management plans/reports, hazard/harm analysis, and FMEAs within a cross-functional team
• Assists teams in developing robust user, product, and labeling requirements
• Ensure that required standards for products are identified and documented in the product requirements (PR) specification and assist teams in demonstrating conformance to applicable standards
• Ensure the use of statistically valid sampling techniques
• Author the Quality, Risk and Usability sections of Design Control Quality Plans (DCQP)
• Provide expertise in evaluating design and process changes for impact to existing verification and validation
• Represent Quality initiatives and compliance when participating and Design and Phase reviews
• Participates in 3rd party audits
• Supports Quality System Software projects

• Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation.
• Knowledge of ISO 13485 and FDA requirements and how they relate to design control, risk management, and other quality practices.
• Good analytical and problem-solving skills.
• High level of attention to detail and accuracy.

• Bachelor’s Degree in Engineering or Science, or equivalent work experience.
• A minimum of two years related manufacturing experience in a QMS environment.
• Strong computer skills, including MS Office applications (Word/Excel) and statistical software are required.

• Risk management
• V&V
• Design Quality
• Audits
• ISO 13485