Danaher Corporation Senior Quality Assurance Engineer in Westborough, Massachusetts
Help us improve access to life-changing therapies that can transform human healthWe are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.We are looking for a QA Engineer to work with our expert Quality team associates across the world. Do you have a passion for Quality? Then we would love to hear from you.What you’ll doActs as QA Lead representative within appointed business projects.Supports the development, implementation, and continuous improvement of process effectiveness and efficiency at the siteEnsures project & process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical processAct as QA approver of QMS records/reports within projectsDevelops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.Leads Root Cause Analysis of nonconformance incidents, including the documentation of completed investigations, CAPA plans and support to Quality letters.Supports the QMS Internal Audit programIdentifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as requiredAware of and complies with the company Quality Management System, Quality Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/positionCompletes all planned EHS and Quality & Compliance training within the defined timelinesIdentifies and reports any EHS and quality or compliance concerns taking immediate corrective action as required .Who you areBachelor’s degree in engineering or health sciences field; or a High School diploma/GED and minimum 6 years work experience in a Quality or Regulatory Assurance related fieldMinimum 5 years’ experience in an ISO 9001, medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related roleExperienced in Customer complaint handling including leading RCA & CAPA plansDemonstrated understanding of product development lifecycles, design change, document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.Basic understanding of materials, properties, manufacturing processes, and product assembly.Experience with cGMP and governmental regulations related to drug manufacturingAbility to read and interpret professional journals and technical procedures.Strong communication and writing skillsProficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.Advanced Engineering/Scientific or Regulatory Affairs degreeProduct-specific knowledge in biomanufacturing or Single Use SystemsDemonstrated program management or leadership skillsDirect experience with cGMP and/or ISO 13485Demonstrated experience prioritizing conflicting demands in a fast-paced environmentDemonstrated strong time management skillsAbility to work independently and in a team settingExcellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).Excellent interpersonal, organizational, and influencing skillsAbility to analyse and process data, and draw the appropriate conclusionsExperience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problemsExceptional analytical, problem solving & root-cause analysis skills with experience of working with continuous improvement tools: (e.g. DMIAC, SPC, Lean SS, 5S)Experience leading and implementing changeExperience performing internal audits and participating in external auditsStrong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.Who we areWhatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.
Danaher Corporation and all Danaher 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 other characteristics protected by law. The “EEO is the Law” poster is available here.
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