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Quality Engineer, Document Services

Company: Fortive
Location: irvine
Posted on: May 3, 2021

Job Description:

COVID-19 update: To keep all of us safe and healthy, we'remaking changes to our job postings and hiring process. Learn more Operating Company: Advanced Sterilization Products category: Corporate location: Irvine, California, United States Posting Date: Jan 19th 2021 Job Schedule (FT/PT): Full-time Job Level: Individual Contributor Requisition Number: ADV001321 The Quality Engineer, Document Services will provide engineering support to the Change Process, facilitatechange orders through the process by effectively guiding change order owners to complete a thorough change and adequate documentation, and support other quality systems functions. Responsibilities: Responsible for scheduling and conducting Change Control Board (CCB) meetings. Provides technical input to conduct a thorough impact assessment of change and ensures the change meets regulatory requirements. Ensures data integrity of each CO to assure clarity and completeness. Verifies change classification, analyzes and evaluates supporting documentation to ensure that each change is effective. Conducts CCB meetings and confirm team consensus, resolve outstanding issues. Promotes good documentation practices and proper management of data and records. Supports process improvement projects to achieve CO and Periodic Document Review metrics. Support teams to investigate quality issues to resolve non-conforming (NC) products, CAPAs, and audit observations. Supports and participates in cross-functional projects when assigned/appropriate. Provides back room support for 3 rd Party Inspections and Audits (e.g. Notified Body, FDA, or customer audits). Supports process improvement projects to achieve CO and Periodic Document Review metrics. Responsible for communicating business related issues or opportunities to next management level. Qualifications: Bachelor's Degree 3+ years' experience within Medical Device, Pharmaceutical, or other regulated industry Knowledge of PLM (Product LifeCycle Management), document and data control software systems is required. Knowledge of FDA and ISO 13485 requirements are required Experience in working with product development and/or manufacturing are required. Knowledge/understanding of the following is preferred, rules of part number interchangeability; effectivity Statements; configuration Management; business Systems Interrelationships, and multi-site, multi-database BOM structure and interactions; and product processes as they relate to manufacturing sites, system hierarchy and control/traceability requirements. Understanding of manufacturing and engineering disciplines are preferred. Ability to work effectively with and lead cross-functional teams for problem-solving and process improvement. Ability to effectively prioritize and manage multiple activities and responsibilities. Outstanding business and technical communication skills (verbal, written, presentation) are required. Fortive is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose: to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress. Here, you get the excitement of a "startup" with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth. There's no limit to what you can learn, or the impact you can make: for you, for us, for growth. Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world. "The company in which you have expressed employment interest is a subsidiary or affiliate of Fortive Corporation. The subsidiary or affiliate is referred to as a Fortive Company. Fortive Corporation and all Fortive Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, ancestry, sex (including pregnancy, childbirth and related medical conditions), age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity or expression, and other characteristics protected by law. The "EEO is the Law" poster is available at: Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1-866-272-5573 or e-mail applyassistance@ to request accommodation." Get tailored job recommendations based on your interests. Category: Corporate Location: Irvine, California, United States Job Type: Full-time Category: Corporate Location: Irvine, California, United States Job Type: Full-time Category: Corporate Location: Irvine, California, United States Job Type: Full-time Category: Corporate Location: Irvine, California, United States Job Type: Full-time Category: Information Technology Job Type: Full-time Category: Corporate Location: Everett, Washington, United States Job Type: Full-time Category: Sales, Marketing & Service Location: Irvine, California, United States Job Type: Full-time Category: Corporate Location: Irvine, California, United States Job Type: Full-time For you. For us.For growth. We have the soul of a start-up, but the benefits and learning opportunities of a larger company. That means you can aspire high, matter more, and distinguish yourself through your contributions.We are a place where people who share a drive and passion to make a personal difference can learn, grow, and achieve. Join Our Talent Community We will notify you about relevant positions, and keep you in mind whenever we have interesting opportunities. Come get them. Fortive Corporation and all Fortive Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1-866-272-5573 or e-mail applyassistance@ to request accommodation.

Keywords: Fortive, Irvine , Quality Engineer, Document Services, Other , irvine, California

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