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Online Resumes with "quality Regulatory"



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Direcor/Sr Manager position in Quality/Regulatory in a Medical Device Industry.

Director of Quality-Regulatory

Developing and Managing successful Quality Organizations and Systems involves more than Compliance. Many organizations strive for Compliance in order to successfully pass audits. I manage Quality Organizations and Systems and maintain Quality and Compliance by focusing on “Objectives”. The Organizations I have managed and Quality Management System’s I have implemented have been done with the following guidelines. • Int...

Tags for this Online Resume: San Diego, Quality, Compliance, Medical Device, Validation, Verification

Featured Profile

Operations Director

Highly organized, driven leader credited with securing multimillion-dollar cost control, top performance, and staff morale improvements within service organizations. Talent for achieving top productivity through expert root cause analysis and problem-solving. Resourceful, fiscally responsible MBA acknowledged for business acumen and success in budget application, product development/launch, vendor relations, team building, ...

Ideal Companies: Kaiser, Exempla, Health one, Level34, Delta Airlines, Comcast, Philips, Siemens, American Express, Xerox, Owens & Minor, Charter Communication, Tele Tech, RTD, Visa, DIRECTTV

Tags for this Online Resume: cost control, multi - site management, budgets, regulatory compliance, safety, strategy planning, Team building, communication skills, Leadership, self - directed, interpersonal skills, operations management, labor relations, customer service, cross - functional team leadership, collections, resource optimization, growth strategy, work force planning, forecasting, problem solving, negotiations skills, balance sheet responsibility, presentation skills, Tactical planning skills, Employee coaching, Training, Sales force, Seibel customer relations management

Over 20 years working experience with Quality Management Systems, with oversight of documentation and records control, corrective and preventive actions (CAPA), quality and regulatory monitoring over design controls, risk management and change control. O

Work within the overall quality management system of the organization providing quality and regulatory compliance suppport and feedback.

Tags for this Online Resume: quality specialist, risk management, change control, documentation control, corrective and preventive actions (CAPA), bilingual

Quality Professional

Efficient, organized professional with excellent communication skills, great attention to detail.

Ideal Companies: Pharmaceutical, Biotech, Medical Device

Tags for this Online Resume: Quality Assurance, Quality Control, Marketing, Customer Service

Featured Profile

Senior Manufacturing Manager - 27 years - Transformation - Lean manufacturing - Team building

I'm a senior manufacturing professional who has over 27 years experience in transforming people, processes and equipment into top performing sustainable teams focused on quality, environmental and cost. Utilizing change management, teamwork and lean manufacturing approaches, I build sustainable and top performance teams.

Ideal Companies: Manufacturing

Tags for this Online Resume: Milwaukee, Operations Manager, Director, Chicago, Lean Manufacturing, Projects, Commissioning, Financial Measurement, Influential, Teamwork, Ohio, Michigan

Quality Systems Manager/Director

Skilled leader with expertise in quality assessment, complaint management, both pre- and post-market product approval, associated regulatory reporting compliance, e.g., pharmacovigilance, field corrective action (FCA), and managing both internal and external quality assessment of operations. Designed, developed, reviewed and implemented quality, regulatory and operational systems. Developed and defined monitored account ...

Tags for this Online Resume: quality systems, regulatory reporting, quality assessment, field corrective action, complaint management, quality assurance

Accomplished Senior Quality and Regulatory Executive

Strategic, Team and Results Oriented high performing Senior Quality executive with 18 years experience in large, mid-size and start-up Pharmaceutical, Medical Devices, Chemical and Bio Pharmaceutical companies. Highly skilled at developing organizations, people and technologies for commercial success. Recognized for leadership in design, development and Implementation of world class Quality, Regulatory and Compliance manage...

Director- Global Operations- 20+ years of experience- Manufacturing of Biologicals-Technical Transfer-develop people-GMP compliance-Regulatory submissions-

Expertise in managing Supply chain for a 1.5 Billion dollar Medical Device Reagents business. Technical, Quality and Regulatory background to manage the business under FDA compliance.

Ideal Companies: Johnson and Johnson, Celgene, Sanofi, Novo Nordisk, Bristol-myers Squibb,

Tags for this Online Resume: Manufacturing Biologics, Protein Purification, Microbial Fermentation, CGMP, FDA Compliance, Protein Characterization, Quality Control, Regulatory Submissions, Quality Audits, Six Sigma Black belt

Featured Profile

Quality Consultant - 8 years Proccess Improvement Experience

Demonstrated effectiveness optimizing the quality and regulatory compliance of multi-hospital healthcare networks, utilizing superb command of root cause analysis (RCA), workflow analysis, concurrent and post-care documentation analysis, and electronic medical record navigation to closely track and resolve patient safety issues. Keen and proactive stance in pinpointing opportunities for process improvements and clinical sta...

Ideal Companies: Hospitals, Consulting firms, Quality

Tags for this Online Resume: Salt Lake City/Ogden, Consulting, Hospital Quality, Process improvement, Six Sigma-White Belt, Project Manager, Variance Trend Analysis, Process Redesign