management levels in FDA regulated health care or medical device industries or in health care related consultancy. Experience... negotiating, problem solving and project management skills. Excellent written and oral communication and presentation skills...
and analysis of various reagent formulations in a regulated manufacturing environment. Analyze trends and monitor/update... and with guidance as necessary from project lead or manager. Influence technical decisions in own area of responsibility. Track...
device industry or other regulated industry required Minimum 3 years Experience in supporting technical project management... required validation and project management documents. Conduct or participate in routine project reviews with Project Teams and Management...
Orientation/BPE, Problem Solving/Resolution - Developing and Project/Project management - Developing Knowledge of Regulatory... Requirements & Compliance - Demonstrating Quality Competencies: Analytical Thinking/Project/Program Management - Developing...
. Demonstrated success in project management, executive communications, and cross-functional leadership. Strong understanding... & Policy in meetings and forums as needed. Change Management & Continuous Improvement Lead or support change management...
Quality Management System and overall quality functions for the West Kearney facility, ensuring compliance with ISO standards... matters and actively participates in quality steering committees across both corporate and manufacturing environments, helping...
systems (including MES, LIMS, local manufacturing, quality control and quality management site IT systems) as well... Technology or similar degree or equivalent experience Skills: Strong project management skills with a proven track record...
, validation, and final production transfer. Act as the project manager responsible for planning, scheduling, risk management.... At least five (5) years of experience as a Project Manager, including project planning, reporting, risk management, and cross...
Oversight Quality Assurance (QA) Technical Witness and Hold Points. Supporting the project management team to interface..., and service deliveries for Westinghouse - from bid phase and component design through manufacturing and delivery...
and external stakeholders. Mentor junior talent in best practices for project management, stakeholder engagement, and continuous...: Exceptional project and program management skills with a track record of delivering complex, cross-functional initiatives on time...
Lead reports to the Operations Manager and will fill a process engineering role for the McIntosh site. This is a working... for critical process parameters Ability to work closely with the Quality Control Manager for Customer Relations Proven...
, Regulatory Affairs will work on-site at our Westford, MA location in the Vascular Division. As a manager, the function... agencies and trade associations and provide executive management with regulatory metrics/information. The individual...
such as constraint manager, variant management, and high-speed signal routing Exposure to military, aerospace, or highly regulated... not own project scheduling, cost, or resource assignment responsibilities. The position operates with a high degree...
/release decisions at an FDA-regulated drug manufacturing facility. The facility manufactures two sterile liquid injection.... This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel...
Strong knowledge of secondary packaging and giftset development Experience working in cGMP or regulated manufacturing environments... Strong communication skills and ability to manage multiple timelines under pressure OUR BENEFITS As our Engineering Project Manager...
Strong knowledge of secondary packaging and giftset development Experience working in cGMP or regulated manufacturing environments... Strong communication skills and ability to manage multiple timelines under pressure OUR BENEFITS As our Engineering Project Manager...
. Project management expertise. Required Leadership Competencies Passion for Continuous Improvement. Strong execution... of Continuous Improvement is highly competent as a process leader and uses a variety of skills such as project/process design...
manufacturing and distribution solution. The Supply Chain Specialist directly reports to the Supply Chain Manager... and creates/maintains Master Checklists (MCL’s) for customer shipping requirements. The Role: Working with Project Management...
, Project Engineering, Manufacturing, and other groups to develop a production plan, inventory strategies, and tactics to manage... shortages) to the management team as well as the manufacturing team to lessen or avoid the impact on the production schedule...
, and successful project execution in a highly regulated manufacturing environment. REPORTING TO: Production Manager DUTIES... & RESPONSIBILITIES: Review customer RFQs, drawings, specifications, and codes/standards to determine project scope and requirements...