Candidate Information Name Available: Register for Free Title Regulatory Affairs Quality Management Target Location US-MN-Wayzata Email Available with paid plan Phone Available with paid plan	20,000+ Fresh Resumes Monthly     View Phone Numbers     Receive Resume E-mail Alerts     Post Jobs Free     Link your Free Jobs Page     ... and much more Register on Jobvertise Free
Search 2 million Resumes Keywords: City or Zip:	Related Resumes Regulatory Affairs Clinical Research Plymouth, MN Quality Assurance Supply Chain,SQE QA,QC Calibration Manager Minneapolis, MN Quality Assurance Medical Device Minneapolis, MN Quality Assurance Medical Device Blaine, MN Quality Assurance Software Development Minneapolis, MN Quality Control Continuous Improvement Minneapolis, MN Quality Assurance Engineer Woodbury, MN

Candidate's Name
PHONE NUMBER AVAILABLE Minneapolis, MN Street Address  EMAIL AVAILABLE LINKEDIN LINK AVAILABLEInnovative and dynamic Quality Management leader with over two decades of proven expertise in the medical device and pharmaceutical industries. Proven expertise in spearheading transformative initiatives, leading cross-functional teams across diverse platforms, and ensuring compliance with industry standard. Seeking to leverage my background in Quality Management and Regulatory Affairs to excel as a Quality Manager.WORK EXPERIENCENovember 2017  Present Minneapolis, MinnesotaPrincipal Quality System Specialist  Quality Leader Medtronic  Enterprise Facilities OperationsSpearhead the quality management system, setting the direction for quality initiatives and metrics.Actively manage and maintain quality systems for the Enterprise Function; Training, Document and Change Control, Deviations, CAPA, Audit and Qualifications.Provide expertise in interpreting policies, procedures, and regulations to ensure compliance with industry standards.Reviewed/approved various forms of documentation (protocols, reports, procedures, etc.) to proactively manage functional quality.Lead and coordinate internal and external audits with regulatory bodies, ensuring successful outcomes.Supervise and direct activities of an External Supplier Quality Manager, overseeing quality assurance processes and adherence to established standards.Train and mentor, a team of experts focused on maintaining infrastructure and production areas, ensuring they meet industry requirements.Collaborate with regional teams to address common issues, adopt best practices, and enhance quality across multiple platforms.October 2015  November 2017 Minneapolis, MinnesotaQuality System Specialist Medtronic  CardiovascularManaged CAPA, nonconformance, and quality-related functions, ensuring compliance and continuous improvement.Collaborate with peers and site leaders to maintain system compliance.Proficient in data acquisition and evaluation to manage quality systems initiatives and generate metric reports.Play a key role during internal and external audits with regulatory bodies, applying DMAIC and Lean Six Sigma problem-solving strategies.April 2015  October 2015 Plymouth, MinnesotaPharma QC Regulatory Specialist ProMed Molded Products, Inc.Develop quality system documents to address regulatory gaps, enhancing decision-making for senior leadership and stakeholders.Lead a team to drive improved quality performance and increased compliance, emphasizing a commitment to regulatory standards.Supervised team responsible for metrology/calibration of instrumentation and equipment.April 2002  April 2015 Brooklyn Park, MinnesotaResearch Associate III, IV & VI Teva Pharmaceuticals Ltd.Enforced policies and procedures, conducted facility and equipment inspections, and provided personnel training.Reviewed/approved analytical data and documentation, prepared regulatory submission documentation.Managed nonconforming events, CAPA procedures, and out-of-specification investigations.Directed a team responsible for calibration and maintenance of analytical instrumentation.Proficient in various analytical instrumentation: chromatography (HPLC), UV-Vis, FTIR spectroscopy, USP dissolution, and Karl FischerEDUCATIONMaster of Business Administration (MBA)Jack Welch Management Institute at Strayer UniversityOctober 2018  June 2020, Completed 5 of 12 Courses.Master of Science in Regulatory Affairs for Drugs, Biologics and Medical DevicesNortheastern UniversityDegree Conferred, 2009.Bachelor of Arts in Biology and ChemistrySt. Catherine UniversityDegree Conferred, 2001PROFESSIONAL SKILLSKnowledge of quality concepts and statistical tools.Proven expertise in regulatory affairs and compliance, including ISO 13485 and 21 CFR Part 820.Strong leadership, communication, and negotiation skills demonstrated through successful collaboration with internal and external stakeholders.Excellent planning and organizational skills, with a track record of making effective decisions that align with business goals and company policies.Proficient in technical writing, analytical problem-solving, and critical thinking, essential for managing quality systems initiatives.Ability to organize and follow up on multiple priorities.