Manager, Medical Device and Combination Product Quality SystemsJoin to apply for the Manager, Medical Device and Combination Product Quality Systems role at AbbVieManager, Medical Device and Combination Product Quality SystemsJoin to apply for the Manager, Medical Device and Combination Product Quality Systems role at AbbVieGet AI-powered advice on this job and more exclusive features.Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.Job DescriptionThe Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport, otherwise in one of our other Ireland sites.Responsibilities:Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.Program-manage initiatives intended to improve and globalize the AbbVie quality management system.QualificationsBachelor’s degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.This is a hybrid role with 3 days on site, 2 days remote.Additional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.htmlSeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionHealth Care ProviderIndustriesPharmaceutical Manufacturing and Biotechnology ResearchReferrals increase your chances of interviewing at AbbVie by 2xSign in to set job alerts for “Medical Manager” roles.Dublin, County Dublin, Ireland 3 weeks agoDublin, County Dublin, Ireland 1 month agoGrade VIII Office of the Integrated Healthcare Area Manager OFFINHEAM AmendedDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 5 days agoDublin, County Dublin, Ireland 15 hours agoArea Support Manager (Dublin Region) - Full-timeDublin, County Dublin, Ireland 1 week agoGrade VI Healthcare Records Manager CHB10825 - AmendedDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 15 hours agoClinical Nurse Manager 1 AB Cleary Ward- Oncolgy/HaematologyDublin, County Dublin, Ireland 11 hours agoNational Clinical Manager UKI - Acute TherapiesDevelopment Manager – Medical Devices – South Dublin/Remote HybridDublin, County Dublin, Ireland 1 week agoAssociate Director, Medical Governance & Risk ManagementDublin, County Dublin, Ireland 2 weeks agoGrade VI Healthcare Records Manager CHB10825 - AmendedDublin, County Dublin, Ireland 6 days agoClinical Nurse Manager 1 (Specialist) - DiabetesDublin, County Dublin, Ireland 20 hours agoDublin, County Dublin, Ireland 17 hours agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 2 weeks agoClinical Development Medical Director - CRMDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 3 days agoClinical Nurse Manager II: Keith Shaw WardDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 1 week agoAssociate Clinical Development Director - CVDublin, County Dublin, Ireland 6 hours agoClinical Development Medical Director - Renal **80-100%Dublin, County Dublin, Ireland 2 weeks agoClinical Nurse Manager II - Day Services (SC24 - 734)Dublin, County Dublin, Ireland 18 hours agoSenior Clinical Development Medical Director - RenalDublin, County Dublin, Ireland 1 week agoSenior Clinical Development Medical Director - RenalDublin, County Dublin, Ireland 1 week agoWe’re unlocking community knowledge in a new way. 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