Exciting opportunity for someone with experience in the medical device field! This is a great direct hire opportunity!
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
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
Location Bellingham
Salary Range is 70-75K to start
Full Benefits package
-Medical Plan
-Vision Plan
-Paid Time Off (PTO)
-Healthcare Spending or Reimbursement Accounts (HSAs or FSAs)
-Retirement Benefit
-Education Assistance or Tuition Reimbursement
-Child Care Benefits
-Employee Discounts