Senior Manager, Design Control

Alere in Springfield, IL

  • Type: Full Time
position filled
Job Description - Senior Manager, Design Control (REQ19100092)Job Description Senior Manager, Design ControlRequisition ID : REQ19100092Primary Location : NA-USA-Illinois-Lake ForestDescription Position Title: Senior Manager, Design Control Location: DO WORK THAT MATTERS At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals. We have an exciting opportunity for a Senior Manager, Design Control within our Abbott Rapid Diagnostics business located at Lake Forest, IL. In this role, you will be responsible managing the Design Control group supporting development of rapid diagnostic products such as instruments, software, reagents, lateral flow devices., and commodities at the global ARDx sites. Abbott Rapid Diagnostics (formerly Alere) is part of Abbott s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. RESPONSIBILITIESResponsible for implementing and maintaining an effective,compliant, global Quality System in the area of Design Control in a regulatedindustryProvides input to ensure product requirements meet customers'expectationsWorks closely with research organization during the entire stagegate process to ensure potential product issues are identified and addressed inthe designCommunicates effectively on project status, success and risks thatcould impact customer satisfaction or project objectivesStrategic, multi-disciplined thinker who develops proposals toaddress issues and resolve risksMaintains development related documentation and establishesprocedures that affect department and R&D sectionsIndependent reviewer of failures and changes during thedevelopment phasePlans and initiates projects to improve process flows andidentifies adequate control pointsLead Community of Practice teams in related areas to identify andpromote best practicesServe as the division liaison for corporate initiatives linked toDesign ControlSupport audits in related areas and any associated resolution ofobservationsSupervise and develop QA professionals providing direction,leadership and support including goal setting, performance assessment/management, growth, etc.Design Control oversight for the global network, with directreports working in regions, supporting the local business needsProvide oversight, guidance and subject matter expertise in theareas of Design ControlManages subordinates who exercise significant latitude andindependenceDemonstrates commitment to the development, implementation andeffectiveness of applicable Quality Processes as per ISO, FDA, and otherregulatory agenciesQualifications BASIC QUALIFICATIONSBachelor s Degree in an Engineering, Quality, or LifeScience discipline, or significant experience (minimum of 10 years) in aproduct development or product development quality support functionMinimum of five years work experience in Quality or R&D Knowledge of regulations and standards affecting DesignControl for rapid diagnostic products (such as instruments, lateral flowdevices, reagents and commodities) preferred Demonstrated capability to lead a team and to execute taskson time Expert at managing complexity and multiple work streams inchanging circumstancesWork collaboratively and communicate effectively withawareness of global cultural differencesAbout AbbottAbbott is a globalhealthcare leader that helps people live more fully at all stages of life. Ourportfolio of life-changing technologies spans the spectrum of healthcare, withleading businesses and products in diagnostics, medical devices, nutritionals andbranded generic medicines. Our 103,000 colleagues serve people in more than 160countries.Connect with us at, on LinkedIn at , on Facebookatand on Twitter @AbbottNews and @AbbottGlobal.An equal opportunityemployer, Abbott welcomes and encourages diversity in our workforce.We provide reasonable accommodation toqualified individuals with disabilities. To request an accommodation, pleasesend an email to ...@alere.com.Job : QualityOrganization : General & AdministrativeSchedule : Full-time

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