State of the art medical device manufacturer in Irvine, CA is seeking a SR Quality Engineer.Description:
Primary job responsibilities include CAPA management audit program management and Quality Management System improvements.
Provides oversight for the maintenance of quality programs systems processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provides expertise and guidance in complying with policies regulatory and/or governmental regulations and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Leads audit and inspection preparation resolution of audit and inspection findings and liaises with auditing groups through all stages of the audits.
Prepares reports and/or necessary documentation e.g. Corrective and Preventative Actions and provides to applicable stakeholders both internal and external.
Develop and maintain Compliance policies supporting the Risk Management program.
Skills:CAPA, technical writing, Quality Management Systems, Medical Device, Risk ManagementAdditional Skills & Qualifications:
Bachelors Degree in Engineering or related degree
5+ years of experience
Familiar with IEC 60601 and product specific industry standards
Auditing experience to 21CFR820.30 21CFR820.100 ISO13485 IS0
Training in Risk Management ISO 14971:2012 hazard analysis and Design FMEA
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
