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Director QA/RA, Digital and eServices

  • Anywhere

Company :
ALERE

Location :
Lake Forest, Illinois

Expiry Date :
Mon, 14 Dec 2020 23:59:59 GMT

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Description :
Director QA/RA, Digital and eServices ["NA-USA-Illinois-Lake Forest"] Director QA/RA, Digital and eServices Lake Forest, IL Abbott Rapid Diagnostics 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. This position will develop and establish strategies, policies, and processes to govern that quality and regulatory requirements are met for Rapid Diagnostics digital products and eServices offerings. The role will ensure procedures and controls are in place for the organization to conforms to established standards and agency regulations. The Role * Define and communicate overall vision and strategies for ARDx digital products, applications and eServices offerings to meet agency regulations and established and developing standards for software and eServices in the diagnostics industry, with emphasis on point-of-care settings. * Provides overall leadership for Quality policies, approaches, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems and policies. * Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, and other regulations governing software, digital applications, data privacy, cybersecurity and other aspects governing eServices offerings. * Provide influential leadership with US and OUS sites to drive proactive quality improvements and harmonization to Abbott quality policies. * Provide diligent and fact-based communication to ARDx Management team, Business Unit leaders, peers, and quality, regulatory and other functional team members in the organization. * Assures Quality provides technical support and services to Engineering, Research & Development and other cross-functional groups involved in development, launch and maintain digital products and e-Services delivery and ongoing oversight. * Be an effective member of the cross-functional organization to foster continuous quality compliance and predictive improvements by maintaining effective Quality Metrics and define and execute activities to resolve performance concerns. * Support all Divisional initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements and programs as prioritized by ARDx leadership. * Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Education and Experience: * B.S./B.A in science or engineering, plus 10 total combined minimum years of experience required. * In quality/regulatory desired with at least 3+ years management of demonstrated compliance excellence, value improvement, risk reduction, and experience with digital and/or eServices support. * In vitro diagnostics experience and software/digital desired. * Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies. * Strong leadership skills with demonstrated ability to create momentum and deliver excellent results. Strong organization, speaking skills, and influential management ability. Ability to work in a highly matrixed and geographically diverse business environment. Ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. * Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable. * Ability to travel approximately 25%, including internationally. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to Sr Management/Executive Full-time