Keystone Computer Solutions, Inc.
(KCS) is a leading technology systems and solutions company,
solving our customers' mission-critical problems through innovative
applications of technology, talent and knowledge management.
Quality Assurance Systems Engineer : Northridge, CA
11/12/2016 7:07:47 AM
Quality Assurance Systems Engineer
Education: Undergraduate Degree
Experience: 5 Years of Experience Job Duties :
*Creates and delivers presentations throughout the organization
*Develops product and process improvements
*Participates in internal supplier audits
*Participates in procedure writing and review
*Performs deliverable checklist audits
*Performs process and equipment validations
*Provides technical support to other engineers
*Supports manufacturing, development, and implementation processes
*Utilizes FMEA within process development
*Generates documentation for engineering protocols and reports
*Implements quality system improvements
*Writes engineering and manufacturing specifications Notes:
*Principal Hardware Quality Engineer Position Description:
*The Principal Hardware Quality Engineer will participate in the execution of new product development and sustaining products and administration of quality assurance programs, policies, processes, procedures and controls in compliance with the evolving and complex US and global requirements of the medical device industry.
*The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against quality system elements including hardware work products to ensure compliance.
*This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet quality, reliability, and compliance requirements.
*This individual will ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes. Position Responsibilities:
*Review all project / program hardware work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
*Plans, develops and implements validation plans for new product development in conjunction with Rand D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.
*Assists Supplier Quality Assurance with supplier audits; interfaces with Purchasing and Supplier Quality Assurance with supplier issues.
*Generates documentation at the project level including system risk assessment, DFMEA, PFMEA, and requirements compliance matrix (ERM).
*Chair cross-functional change control boards (known as Change Review Group (CRG)).
*Assist in the analysis of field returns and in-process non-conformities.
*Perform and lead CAPA projects and activities.
*Provide training, when required, to personnel engaging in design and development, verification and validation, inspection, documentation, and manufacturing.
*Participate in technical hardware/system design reviews, CCB (Change Control Board) reviews, PQRB (Product Qualification Review Board) reviews, and PAB (Phase Approval Board) reviews.
*Provide guidance and direction to other engineers and technical support staff.
*Drive SOP/DOP updates or creation of new processes based upon upcoming standards or process improvements.
*Identify and support cost-saving programs and process improvements.
*Apply and improve advanced technical principles, theories, and concepts in the monitoring and coordination of various design, development, testing, and quality activities.
*Work under consultative direction toward predetermined long-range goals and objectives.
*Assignments are often self-initiated.
*Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
*Performs other related duties as assigned. Basic Qualifications:
*Bachelor???s Degree in Engineering with 7 years??? related experience in engineering and/or quality assurance in a regulated industry (e.g., FDA-regulated, FAA-regulated, DoD, CMMI ML 3+) Job# - 5039 Quality Assurance Systems Engineer