Westborough, Boston, Hartford, Nashua, Providence
Connecticut, Massachusetts, New Hampshire, Rhode Island
This position is responsible for providing Quality Control engineering process support in accordance with documented procedures and practices. The Quality Continuous engineer is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Control fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and service.
• Identify and address areas that require process improvement within the QC group.
• Develops 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.
• Supports continuous process improvement through detailed failure analysis for nonconformances, and investigates, develops, and implements effective and compliant solutions for process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
• Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
• Performs a broad variety of tasks in support process design as assigned by the departmental manager.
• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance.
• Bachelor’s Degree in an engineering or technical discipline (or a minimum of 4 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements with a minimum of 3 years’ experience working in a regulated industry).
• Demonstrated understanding or aptitude to understand regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Knowledge of ISO 9001 & Quality Control experience
• Demonstrated knowledge and understanding of Continuous Improvement mindset
• Demonstrated understanding of design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies.
• Demonstrated collaboration, negotiation & conflict resolution skills
• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level related processes
• Excellent oral communication & report, business correspondence & procedure-writing skills
• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
• Exceptional analytical, problem solving & root-cause analysis skills
• Ability to multi-task & handle tasks with competing priorities effectively
• External Focus: Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment
• Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely
***Candidates should note that this role will be in scope for the proposed transition of GE Biopharma to Danaher and will transfer to Danaher at close of this transaction. ***
GE Healthcare Life Sciences www.corporate.gehealthcare.com There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can. Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Additional Eligibility Qualifications
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).