Amick Brown is seeking an experience CAPA Quality Engineerfor our direct client.
Location: Remote, CA Duration: 1 Year Job Description
The Post Market team at ISI works at the intersection of Regulatory and Quality.
The team engages across the organization to deeply understand how our products and processes perform, the implications of any issues and, support the execution of robust resolutions.
Functions within the Post Market team include Post Market Surveillance, Field Action, Data Analytics, Clinical Engineering, Failure Analysis Engineering, and Continuous Improvement Quality Engineering.
The Post Market Team advocates for safety and effectiveness improvements by assessing field product performance and QMS processes to identify, investigate, communicate, and execute on opportunities.
The Continuous Improvement Quality Engineering Team requires a Sr. Continuous Improvement Quality Engineer with strong, hands-on experience in problem solving, technical savvy with complex electro-mechanical devices, and passion for the best practices to analyze, monitor, and improve product and process.
Roles & Responsibilities
Reporting to the Sr. Manager, Continuous Improvement Quality Engineering, the Sr. Continuous Improvement Engineer is responsible for creating and supporting a quality culture by driving compliance activities around the CAPA Program, partnering across the organization to manage continuous process/quality improvement programs that strongly align with ISI standards and customer needs while meeting all applicable Medical Device Regulations and Standards.
S/he will partner with subject matter experts on various corrective and preventive (CAPA) activities in addition to supporting other improvement initiatives.
S/he will evolve existing processes/systems to ensure timely escalation identification of product quality & compliance issues within a closed loop quality management system.
The CIQE will work to collect and analyze data, drive rigorous root cause analyses and facilitate cross-functional discussions to ensure we are seeing ‘all the way around’ issues for complete resolution.
S/he will participate in internal/external audits as necessary representing the CAPA Program.
Bachelor’s degree (Engineering or equivalent) combined with 6-8 years of related experience in Quality, Engineering, Operations, or a continuous improvement environment.
Strong interpersonal and communication skills:
Passionate about making products and processes better
Able to assist people in finding creative solutions around constraints.
Able to deliver presentations to a broad audience
Knowledge of Quality Systems Regulations (21 CFR 820) and ISO 13485 preferred.
Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred.
Green or Black Belt Certification in Lean or Six Sigma is a plus
ASQ certification (CQE) is a plus.
Experience gathering/processing internal and external requirements.
Business Acumen - has demonstrated business knowledge and ability to display the linkage between projects and desired business results.
Proven ability to drive creative problem solving related to product and process issues
The ability to collaborate effectively with product and/or process subject matter experts in a cross-functional team environment is required.
Technical Aptitude is required to collect and analyze data for determining an improvement strategy
Ability to navigate multiple projects with changing priorities. Ability to execute to project timelines.
Project Management experience preferred.
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California. Regular full-time employees are eligible for the following Amick Brown provided benefits: