Senior Quality Systems Specialist - Medical Device #2899

Senior Quality Systems Specialist - Medical Device #2899 Enhanced Compliance Inc. - 3.3 Santa Clarita, CA Job Details 1 day ago Qualifications Quality control corrective actions Bachelor's degree in mechanical engineering Bachelor's degree in electrical engineering Audit engagement planning ISO standards 5 years Engineering Regulatory compliance Bachelor's degree in biomedical engineering Mechanical Engineering Compliance audits & assessments Biomedical Engineering Corrective and preventive actions (CAPA) Quality assurance audits Bachelor's degree in engineering Bachelor's degree Senior level Electrical Engineering Full Job Description About ECI ECI's mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. About the Role The position will plan and lead internal audits to assess compliance with regulatory standards and client requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. What You'll Do Execute internal audits per the defined audit schedule Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. What We Look for Minimum of 5+ years direct experience in medical device industry Certified

ISO 13485

Lead Auditor Education:

Bachelor's degree in biomedical/ mechanical/ electrical engineering or equivalent is required Experience executing CAPA activities Demonstrate Strengths in - Identifying creative and efficient solutions to engineering challenges, Translating customer requirements into workable product ideas and solutions. Good analytical and problem-solving skills. Broad and in-depth regulatory knowledge in medical device (Class II and III medical devices) ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.