Sr. QA Engineer - Quality Assurance

Company: Cytiva
Location: Muskegon
Posted on: January 27, 2023

Job Description:

Be part of something altogether life-changing!Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we are pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.What you'll doSupport the execution the QMS implementation action plan defined by the QARA Project leader.Accountable for developing and maintaining the Site QMS training matrix , be the Subject Matter Expert (SME) in the eLearning system, Cytiva Learning (Cornerstone).Accountable for QMS trainings assignments as well as support site Quality induction activities.Accountable for QMS document management, including but not limited to; leading the site document review board, authoring of local QMS work instructions, liaising with the Global QMS team on Global documentation updates and acting as the site administrator for the Cytiva electronic documentation management system (eDMS), Veeva Quality Docs.Be the local system administrator for the Cytiva eQMS; deviations, investigations, CAPAs, Changes (Change Controls) and internal audits. As system administrator, represent the site in global superuser forums ensuring site needs are identified, system updates are implemented and communicated. Lead system specific training and approve system access for associates.Responsible for on-site Quality Assurance support to the technology transfer project for all quality related topics.You will be part of our ongoing security of supply initiative to build a new chromatography media manufacturing site, the product transfer from our manufacturing site in Uppsala Sweden and to build up the Quality Management System for the site.Who you areMinimum, Bachelor's degree from an accredited University or College, preferably in a Science or Engineering disciplineA minimum 5 years working experience in Quality Assurance/Quality Engineering within Life Science, Medical Device or Biopharma manufacturing environmentsComprehensive understanding of ISO 9001 & ISO 13485 requirements Understanding of GMP requirements, desiredExperienced in working cross - functionally, both locally and globallyExperience of working with implementing Quality Management Systems, and working with documents and training desiredStrong analytical- and problem-solving skillsStrong communication skills (written and oral).Strong interpersonal skills, including escalation managementConfident when working independently and as part of a teamStrong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)Travel to Uppsala will be required.When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.If you've ever wondered what's within you, there's no better time to find out.

Keywords: Cytiva, Grand Rapids , Sr. QA Engineer - Quality Assurance, Other , Muskegon, Michigan