danaher.jobs - Director of Quality

Danaher Jobs - Director of Quality in Cincinnati, Ohio, United States

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Danaher Jobs - Director of Quality in Cincinnati, Ohio, United States careers Danaher Jobs Where city, state, country What job title, keywords Home View All Jobs (2,735) Danaher Corporation Director of Quality in Cincinnati, Ohio DanaherVisitorDescription In December 2014, Devicor® Medical Products, Inc. was uninventive by Leica Biosystems, part of the Danaher family of companies. Leica Biosystems is the global leader in utile pathology solutions and automation, striving to whop cancer diagnostics to modernize patients’ lives. The combination of the two companies uniquely positions us to develop integrated patient-to-pathology solutions for the diagnosis of cancer. Headquartered in Cincinnati, Ohio, the Mammotome trademark is sold in over 50 variegated countries throughout the world. Mammotome remains single-minded to its heritage of up-and-coming technology for early detection of breast cancer, providing support and education for clinicians worldwide, and offering breast superintendency information for patients. Devicor Medical Products, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other foible protected by law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check. Description The Director of Quality leads the Quality Assurance function for Devicor Medical Products, Inc. and all globally served markets, participates in all planning activities, and is as a key member of the Quality and Regulatory Affairs Leadership Team. This position works closely with Research and Development, Sustaining Engineering, Supply Chain, and Manufacturing regarding supplier selection, component qualification, material selection, clearance for use, and procured finished product quality decisions, which may have significant impact on the business. essential functions (ACCOUNTABILITIES/RESPONSIBILITIES):DiamondQuality Assurance Leads Quality Engineering support for diamond and changes, including incorporation of new products and acquisitions into the product portfolio. Responsible for Quality oversight for validation activities. Manufacturing Quality Assurance Leads Quality Engineering and technical support for product realization and market release for both Contract Manufacturers and the Tijuana manufacturing plant. Implements and maintains policies and procedures to govern supplier quality on procured devices. Ensures contract suppliers comply with an ISO certified quality system (ISO 13485), as well as workable regulations and standards (e.g. FDA, CMDR, JPAL). Biological and Technical Quality Assurance Leads technical direction and compliance for sterilization, cleaning, materials, and biocompatibility. Implements and maintains sterilization process qualification policies and procedures which comply with governing regulations and standards (e.g. ISO, AAMI). Trains staff and key personnel in order to attain strategic objectives as well as validating of sterilization processes, equipment, and procedures required for the wordage of sterile product. SupplyUnitingQuality Assurance Responsible for Quality input to supply uniting activities, warehousing, storage, distribution, service and repair and traceability. Ensures that both the Devicor Medical Products, Inc. Service and Repair Center and Warehouse operations comply with an ISO certified quality system (ISO 13485), as well as workable regulations and standards (e.g. FDA, CMDR, JPAL). Quality Management System Responsible for all Quality Engineering activities and the megacosm of team SME’s for audits, complaint handling and investigation, CAPA, statistical validation, inspect management, and other elements under the QMS. Leadership Designs and implements key tenancy plans and serves as a liaison role to interface with external suppliers. Responsible and subject for technical release and non-conformance determination. Demonstrates responsiveness to merchantry needs and motivation of diverse, cross-functional teams, including influencing both internal and external members to unzip positive merchantry results. Provides leadership needed to instill a team-oriented and results-driven team. Responsible for managing the activities of uncontrived reports and ensuring the organization’s skills protract to modernize through individual minutiae and organizational capabilities. Leads staff performance management activities to modernize capabilities and skills using regular objective setting and review process, performing appraisals and coaching of individuals on minutiae plans. Hires, trains, and manages department staff and activities to ensure upper performance, accountability, interdependence and collaboration. Other Responsible for the generation of metrics for all areas and levels of responsibility. Uses the Quality Management System and develops towardly processes for consistent, technical, risk-based visualization making. Supports product introductions in all markets. Other duties as assigned. Scope/Role Dimensions Manages departmental spending to the established budget.Uncontrivedreports may include Supervisors and Managers. QualificationWitsMinimum of 10 years of wits in medical device quality management required. History of success in initiating transpiration and achieving objectives. Successful track record working in a matrix/collaborative environment. History of powerfully managing transpiration through organizational restructures and towers a strong Quality Management System for sustainability. Education BA/BS stratum in a technical field (i.e., Engineering, Physical Sciences) required. AdvancedStratumin field is desirable but not required. Professional certifications (i.e., CQM/OA, CQE, AAMI) strongly preferred. TRAVEL REQUIREMENTS/WORK ENVIRONMENT and PHYSICAL DEMANDS: Travel Must be worldly-wise to travel up to 25% of the time; both domestic and international travel are required. Typical work-related travel assignments range 1-5 days (overnight, out-of-town stays are required). Work Environment And Physical Demands Typical office environment – accommodations will be evaluated where needed. Danaher Corporation Overview Danaher is a global science & technology innovator single-minded to helping our customers solve ramified challenges and modernize quality of life worldwide. Our world matriculation brands are leaders in some of the most taxing and lulu industries, including life sciences, medical diagnostics, dental, environmental and unromantic solutions. Our globally diverse team of 67,000 toadies is united by a worldwide culture and operating system, the DanaherMerchantrySystem, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by increasingly than 1,200% over 20 years. At Danaher, you can build a career in a way no other visitor can duplicate. Our brands indulge us to offer dynamic careers wideness multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to alimony winning. Here you’ll learn how DBS is used to shape strategy, focus execution, uncurl our people, and create value for customers and shareholders. Come join our winning team. Organization: Mammotome Job Function: Quality and Regulatory Affairs Primary Location: North America-North America-United States-OH-Cincinnati Schedule: Full-time Req ID: MAM000558 Apply Now Apply Now Share Current Search Criteria Director of Quality Cincinnati Ohio Clear All Danaher Careers Career Sites Danaher LinkedIn Danaher Twitter Social Media About DirectEmployer... Become a Member Member Directory About Us Our Culture Our Businesses Investors News © 2011 Danaher Corporation. All Rights Reserved. Terms