We are hiring for an exciting opportuinty! Do you have experience in the medical device industry? We want to talk to you! This position offers great compensation and benfits!
Qualifications • A four-year degree in engineering, law, medicine, pharmacy, or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; OR four years of professional experience in regulatory affairs or in quality management systems relating to medical devices • Experience in conducting ISO or regulatory audits • Proficient in technical and report writing, strong verbal and presentation skills • Strong knowledge of quality management principles, practices, and methodologies • Familiarity with FDA and EU MDR regulations • Strong knowledge of OSHA and WA Labor & Industry regulations • Familiarity with EHS (Environmental Health and Safety) practices • Ability to conduct root cause analysis, analyze data, identify trends, and make data-driven decisions • Proficient in project management techniques, including planning, organizing, and monitoring project progress • Must be a U.S. citizen or national, U.S. permanent resident (current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum • No travel • High school or equivalent (Required) • Bellingham, WA 98226: Relocate before starting work (Required)
Responsibilities • You will be responsible for sustaining and improving the Quality Management System (ISO13485) to ensure that our products meet the highest quality standards and comply with all relevant regulations as well as, implement and maintain safety programs to ensure a safe work environment • Develop and maintain quality documentation, including standard operating procedures (SOPs) and work instructions in accordance with ISO13485 • Develop and implement quality control processes to ensure product consistency and compliance with FDA and EU MDR regulations • Collaborate with cross-functional teams to maintain, enhance, and implement quality systems and processes • Participate in internal and external audits to ensure compliance with regulatory requirements • Manage customer returns; lead investigations into non-conformances and customer complaints, identifying root causes and implementing corrective actions • Provide training to employees on quality systems, procedures, and best practices • Coordinate safety training programs for employees, including CPR, first aid, and other relevant topics • Monitor compliance with OSHA and EPA standards • Collaborate with management to develop and implement emergency response plans • Develop, implement, and maintain safety policies and procedures • Support safety committee in conducting regular inspections to identify potential hazards and recommend corrective actions • Investigate accidents, incidents, and near misses to determine root causes and develop preventive measures • Stay up to date with changes in ISO13485, MDR, safety regulations and industry best practices • Support the development and implementation of continuous improvement initiatives