Sr. Quality Engineer - Design Quality

Osteal Therapeutics is seeking a Senior Quality Engineer to lead design quality initiatives for medical device and pharmaceutical combination products. This role is crucial in ensuring product quality and compliance throughout the development lifecycle, from concept to commercialization. The position involves working with cross-functional teams to maintain regulatory compliance with FDA and ISO standards, leading risk management activities, and overseeing design verification and validation processes. The ideal candidate will have extensive experience in medical device quality engineering, particularly in orthopedic hardware or drug delivery systems.

The role offers an opportunity to work at the intersection of medical devices and pharmaceuticals, requiring expertise in both domains. You'll be responsible for maintaining design control activities, conducting risk assessments, and ensuring product safety and effectiveness. The position demands strong analytical skills for reviewing design documentation and technical specifications, while also requiring excellent communication abilities to work effectively across departments.

This is an excellent opportunity for a quality engineering professional looking to make a significant impact in a company developing innovative medical solutions. The role offers comprehensive benefits, including equity ownership, making it an attractive position for someone seeking both professional growth and financial rewards. The work environment promotes collaboration, continuous improvement, and values diversity, making it an ideal setting for professional development in the medical device industry.