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Online Resumes with "Preventative Action"

OPERATIONS / QUALITY ASSURANCE / SAFETY MANAGEMENT

Over 18 years of top performance in optimizing operations for up to 60K+ SF R&D facilities. A peak performer in establishing operational excellence in all facets of pre-clinical studies, encompassing best practices for quality, safety, compliance, and cost control. Adept at managing quality assurance for studies supporting pharmaceutical/biotech regulatory submissions by conducting independent audits, issuing audit reports...

Tags for this Online Resume: Operations Manager, Animal Research, GLP, Safety, Validation, FDA

Quality Engineer

Proven track record in coordinating and participating in root cause / corrective / preventive action activities CAPA, and driving defect levels down. Proven track record in and enjoy understanding the Customer’s needs / concerns and bringing the Customer focus to the appropriate internal folks and suppliers. Experience working with suppliers, with teams developing and releasing new products to Manufacturing, and with Quali...

Goal focused Quality Leader in medical devices and pharmaceuticals

Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...

Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.

Tags for this Online Resume: Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs

Shaun Fowler, years and years of safety, quality and productivity experience

Shaun Fowler Summary of Experience Culture of safety, quality and productivity: As Vice President of Operations I was responsible for the day-to-day management of two business segments within one 100,000 square foot facility. Each segment consisted of a natural work team consisting of a segment manufacturing manager, supply chain manager, process engineer and one or more sales associates and floor associates (machine ope...

Corrective Action Preventive Action Process Specialist - Novartis Consumer Health

To work in a challenging environment and secure a position in terms of leadership and teamwork which provides opportunities and scope for a responsible professional growth.

Tags for this Online Resume: Quality Engineer, Manufacturing Engineer, Production Engineer, Continuous Improvement Engineer, Industrial Engineer, Statistical Process Control

Regulatory Pharmaceutical Document Specialist and Technical Writer

Brenda is a Technical Writer and Quality Assurance Regulatory Document Specialist with over ten years of experience in the pharmaceutical industry. She has extensive experience with all types of document project work, including writing, editing, formatting. She has experience as a team member for non-conformance investigations (NCs) and Corrective Action and Preventative Actions (CAPAs). Her analytical and research skil...

Quality Engineer, Wichita, Kansas

To immediately contribute to the success of a company's Quality Management Systems. This would be done through the use of my extensive experience in the field of Quality, along with the vast amount of training that I have received.

Tags for this Online Resume: Lean Manufacturing, Corrective / Preventive Action, Project Management, Continual Improvement, Auditing , Six Sigma

Manufacturing Engineer, Central New York

Apply my extensive experience and qualities within an industrial setting where my skills can be fully utilized to improve overall safety, quality, delivery and cost targets while delighting my employer and achieving personal fulfillment. Be the best, build the best.

Tags for this Online Resume: Medical Device Validation, Lean and Six Sigma, Corrective Action Preventative Action, Precision Machining, Regulatory, Leader, Team Leader, Regulatory Compliance, Process Optimization

Program, Quality and Regulatory Manager

Experienced Quality Manager with a proven record of developing the methodologies and tools to help companies manage organizational change, meet customer requirements and provide product excellence. Has extensive project team and department management experience in Quality Management and Regulatory Engineering, primarily for information systems, telecommunications and medical applications. Highly analytical, dynamic, resul...

Ideal Companies: Juniper, Tellabs, Sonus, Sycamore, Wyeth, Phillips, Siemans

Tags for this Online Resume: Program and Project Management, Business Analysis/Process and Data Analyst, Software Quality Assurance (SQA),, Requirements Management, Configuration Management, Defect Management, Quality Systems Development and Quality Management, Business Process Vision and Policies, Organizational Development and Re-engineering, Business Systems Requirements Specification, Course Development and Technical Training, Process and Training Documentation and Technical Writing, Product Design and Qualifications (power and packaging), Component Engineering (analog and materials), European and Asia Pacific business experience, Data Base Development and SQA, Use Case Modeling, Requirements and Defect Management, Issue Management, Document Management, KPI Definition, Analysis and Business Process Improvement, Use Cases Development, Test and Training, Internal Audit Planning, Implementation and Management, Hardware and Software PLC Management, Software Development Life Cycle (SDLC), Product Safety, EMC, EMI Environmental Management, Manufacturing, Customer and Field Support, Standards and Regulatory: UL, CSA, IEC, ISO, VDE, BSI, KEMA, FCC, FDA, PTT, BABT, OSHA, NEC, Sarbanes-Oxley (SarbOx/SOX), COBIT, Standards Making Committees: ECMA TC12, CBEMA ESC2, TIA, Process Frameworks: ISO 9000:2000 and TL 9000 (cGMP/QS9000 equivalent), CMMI, ITIL, SWBoK, PMBoK, RUP, and Sarbanes-Oxley compliance, Mass Quality Award/Baldridge Evaluation/Implementation, ODI and Rummler-Brache Process Improvement Methods, Metrics and Tools: TQM, SPC, TL9000 and GR-929 metrics implementations and Six Sigma tools and methodologies

TS16949 Lead Auditor and Quality Manager

Accomplished ISO/QS9000/TS16949 Lead Auditor with significant experience in the quality industry. Recently trained in ISO14001. Background includes developing quality systems to QS9000/ISO9000/TS16949 standards. Proven leadership capabilities and organizational skills coupled with an extensive ability to pay particular attention to detail. Skilled in quality, staff supervision, problem solving, troubleshooting, compute...

Ideal Companies: Ford, General Motors, Chrysler, Delphi, Visteon, Lear

Tags for this Online Resume: Quality

Experienced individual in all aspects of Pharmaceutical operations, I will contribute right away to benefit your organization.

I am looking for an organization that values its employees. I am ready for a challenging position within a pharmaceutical/biotech industry

Ideal Companies: Imclone, Merck, Shering-Plough, LifeCell, Integra, Actavis

Tags for this Online Resume: Experienced, Quality, CAPA, Tech Writer, GMP, FDA, manufacturing, leader, Microsoft Suite, CQA, Six Sigma, Lean Manufacturing, Quality Assurance, inspection, process excellence, bilingual, BA, Masters

Instructor & Manager of Manufacturing.

MCM-University Manufacturing Capabilities Management BS Degree in Manufacturing Capabilities Management degree program. Economic development through education stimulus management Micro Business Incubator Management and development Work Team and problem solving skills development Manufacturing Technology Management APPRENTICESHIP and INTERNSHIP WORKFORCE DEVELOPMENT PROGRAM PROPOSAL BY Gilbert Gary Mendoza Contact ...