We are hiring a Design Controls Manager to lead and optimize design control processes for medical device development. This remote role involves close collaboration with Regulatory, Quality, and R&D teams to ensure products meet global compliance standards while supporting efficient and timely product launches.  

Key Responsibilities 

•  Lead and improve design control processes for medical devices 
•  Collaborate with global teams to streamline product development workflows 
•  Ensure compliance with international regulatory standards
•  Conduct audits and resolve non-conformance issues 
•  Perform gap analysis and recommend process improvements 
•  Deliver training on design controls and quality processes 
•  Mentor R&D and QA teams on compliance best practices 
•  Support internal and external audits as a subject matter expert 

Requirements
 

•  Bachelor’s degree in Engineering, Science, or related field (or equivalent experience) 
•  5+ years in Quality or R&D within the medical device industry
•  Strong knowledge of QSR, ISO 13485, and MDSAP
•  Experience with QMS systems (CAPA, risk management, audits) 
•  Proven leadership and cross-functional collaboration skills 
•  Excellent communication and problem-solving abilities 
•  Willingness to travel up to 25% (including international) 

Benefits
 

•  Competitive salary ($99K – $198K) 
•  Fully remote work environment 
•  Career development and training opportunities 
•  Health and wellness benefits 
•  Exposure to global projects and teams