Design Quality Assurance Specialist
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In this role, you'll have the opportunity to make a meaningful impact on patient safety and product quality.
* You will lead critical reviews of new and modified product designs to ensure compliance with industry standards and regulations.
* A typical day in this position involves collaborating with cross-functional teams to identify and mitigate risks associated with product design and development.
* This includes reviewing and implementing changes to internal processes and procedures to maintain compliance with regulatory requirements.
* To be successful in this role, you'll need a bachelor's degree in engineering or quality management, minimum 2+ years of experience in a regulated industry, knowledge of ISO 13485, risk management, and verification/validation test plan development.
Key Responsibilities:
* Lead critical reviews of product designs to ensure compliance with industry standards and regulations.
* Collaborate with cross-functional teams to identify and mitigate risks associated with product design and development.
* Review and implement changes to internal processes and procedures to maintain compliance with regulatory requirements.
* Maintain knowledge of industry standards and regulations, including ISO 13485, EU-MDR, and FDA Quality System Regulations.
* Develop and implement risk management plans to mitigate potential risks associated with product design and development.
* Analyze data and provide recommendations to improve product quality and reduce risk.
Requirements:
* Bachelor's degree in engineering or quality management.
* Minimum 2+ years of experience in a regulated industry.
* Knowledge of ISO 13485, risk management, and verification/validation test plan development.
* Familiarity with statistical software tools (Minitab, Stat Graphics) and stability, biocompatibility, sterilization, ship testing, HALT/HASS.
* Familiarity with DMAIC or DMADV(DFSS) methodologies and DFSS/Learn Green Belt preferred.
What We Offer:
* Ongoing training and professional development opportunities.
* A collaborative and dynamic work environment.
* The opportunity to work on challenging projects that impact patient safety and product quality.