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Achievement-oriented professional with proven leadership skills focused on exceeding results through mentoring high potential associates. Formulates and implements strategies to ensure product quality, regulatory compliance and timely product approvals. Experienced in regulated environments that encompasses medical devices, In-Vitro diagnostics, pharmaceuticals, biologics, human tissue products and interface activities relating with ISO and FDA regulators. Innovative collaborator with problem solving focus and sound judgment to resolve difficult issues. Directs teams to ensure that risk management, manufacturing and quality system requirements are integrated into the development process in an efficient and effective manner. Adds value through analytical proficiences complemented with customer service mindset and project management expertise in medical device manufacturing industry.
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Vice President, Edwards Quality LaboratoriesEdwards Lifesciences Apr 2022 - PresentIrvine, Ca, UsGlobal leader, responsible for Edwards Quality Laboratories (EQL) -
Senior Director Quality AssuranceAbbott Jan 2019 - Apr 2022Abbott Park, Illinois, UsSenior Quality Director and Management Representative for the San Diego Rapid Diagnostics Division and Carlsbad Regent Manufacturing Center of Excellence. -
Director Of Quality AssuranceMedtronic Sep 2015 - Jan 2019Minneapolis, Mn, UsLeading the development of quality strategies, goals and objectives for the Diabetes Service and Solutions Business Unit. -
Director, Supplier Quality EngineeringMedtronic Feb 2014 - Sep 2015Minneapolis, Mn, UsRespnsible for the evolution of the Purchasing Controls and Supplier Quality Engineering quality system, policies, processes, and procedures for the Medtronic Diabetes Group.
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Site Quality Compliance LeaderAmgen Jan 2013 - Jan 2014Thousand Oaks, Ca, UsResponsible and accountable for compliance at the Thousand Oaks site for the manufacturing of Biopharmaceuticals, Small Molecule Pharmaceuticals and Combination Products for clinical and commercial products. -
Director Of OperationsNamsa Aug 2008 - Jan 2013Toledo, Oh, UsDirector of Operations for NAMSA, the world’s leader in contracted medical device testing. Responsible for the overall operations of validation, pre-clinical and post release testing activities. Servicing the leading Medical Device, Biologics and Pharmaceutical clients. -
Director Of Quality Assurance And Regulatory AffairsNamsa Jul 2005 - Aug 2008Toledo, Oh, UsResponsible for maintaining the quality systems to ISO 13485, ISO 17025 audits, GLP, cGMP and GMP. Served as the Quality Management Representative for all laboratories. Ownership and responsibly of the overall change control process, internal audits, corrective and preventive actions, external vendor audits, statistical process control, management review, quality assurance and quality control systems, validations, instrument requalification activities, customer complaints, client audits, and engineering / metrology activities.
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Analytical Quality Assurance ManagerAbbott Diagnostics Nov 2000 - Jul 2005Abbott Park, Illinois, UsRecruited to help Abbott Laboratories’ Diagnostic Division resolve quality deficiencies resulting in the largest ever FDA imposed Consent Decree. Managed the quality system which covered change control, Good Manufacturing Practices (GMP), spec setting, statistical process control, corrective and preventative actions, failure investigations, validation, quality metrics, product availability for the Architect and AxSym AQA Laboratories.
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Assistant Laboratory ManagerMercy Health (Formerly Mercy Health Partners) 1999 - 2000Cincinnati, Ohio, UsManaged daily operations from the budget to staffing, reporting, test collection and testing results for the CLIA approved hospital clinical laboratory. Emphasis on quality assurance, quality improvement and customer service.
Michael Oberle Skills
Michael Oberle Education Details
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Bowling Green State UniversityClinical Laboratory Science/Medical Technology/Technologist -
The University Of ToledoCellular Biology
Frequently Asked Questions about Michael Oberle
What company does Michael Oberle work for?
Michael Oberle works for Edwards Lifesciences
What is Michael Oberle's role at the current company?
Michael Oberle's current role is Vice President, Quality.
What is Michael Oberle's email address?
Michael Oberle's email address is mi****@****ast.net
What is Michael Oberle's direct phone number?
Michael Oberle's direct phone number is (419)-666*****
What schools did Michael Oberle attend?
Michael Oberle attended Bowling Green State University, The University Of Toledo.
What are some of Michael Oberle's interests?
Michael Oberle has interest in Sweepstakes, Investing, Electronics.
What skills is Michael Oberle known for?
Michael Oberle has skills like Fda, Medical Devices, Capa, Validation, Iso 13485, Quality System, Gmp, Quality Control, Quality Assurance, Pharmaceutical Industry, Glp, Quality Auditing.
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