A Quality Management Representative ensures that the QMS processes are established, maintained, and implemented. A well-written Quality Management Representative Resume mentions the following core duties and responsibilities – reviewing and planning of internal audits, discussion with process owners, reviewing of the processes in person, and ensuring they are properly maintained, ensuring that each process is functioning well, and supporting fully for quality management systems implementation. Part of the job description includes ensuring that the processes needed for the quality management systems are established, and ensuring the promotion of awareness of customer requirements throughout the organization.
The following characteristics and skills will be effective in this role – strong knowledge of ISO 9000 requirements; broad knowledge of the company’s operations and its QMS; the ability to listen and influence; and project management and organizational skills. A degree is commonplace among job applicants.
Summary : Highly qualified Quality Management Representative with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and I would excel in the collaborative environment on which your company prides itself.
Skills : LEAN, DMAIC, Medical Device, FDA Remediation.
Description :
Oversaw all aspects of the Plasmapheresis process from medical history, physical exam, donor floor, sample prep, shipment, lab results and donor notification of abnormal results, reviewed all paperwork as they pertained to each area.
Handled all FDA, iQPP, EMEA, OSHA and internal audits.
Completed audit follow up and responses.
Performed weekly, monthly, quarterly and yearly inspections as required.
Ensured all employees were following guidelines outlined in current SOP, HIPPA laws, OSHA and FDA.
Maintained a solid working relationship with centers Medical Supervisors and Medical Director.
Supervised the donor floor area and Sample prep.
Experience
10+ Years
Level
Senior
Education
Associates In Electrical Engineering
Quality Management Representative Resume
Summary : As a Quality Management Representative with over 20 years of experience in manufacturing, distribution and quality management, acquired the skills, training, and methods to develop team members, work cultures and organizations with an emphasis on employee engagement and process improvement. Some of my major accomplishments and areas of expertise include culture transformation, coaching, critical thinking-analysis and reducing and or eliminating injuries, cost and waste.
Skills : Six Sigma Master Black Belt, LEAN Facilitator, CAP SME, Risk Management, Supplier Quality.
Description :
Led the implementation & administration of Quality Management Systems.
Returned Goods Authorizations, Tool Calibration, Analyze Process Control Plans, and Statistical Process Controls.
Ensured compliance to Underwriters Laboratories, Dept.
Developed and implemented the annual Internal Audit plans.
Provided support in the implementation and maintenance of safety and environmental regulations.
Conducted supplier audits and evaluations and communicate performance results.
Collaborated with Engineering and the Technology division to assist in the development of new products.
Experience
10+ Years
Level
Senior
Education
Associate's
Quality Management Representative Resume
Objective : As a Quality Management Representative, responsible for Preventing mistakes and defects in products avoiding problems when delivering solutions or services to customers, and also Enabling and coaching all employees to evaluate risks, problems, and solutions from a customer/stakeholder point of view.
Assisted with the development and maintenance of a safe work environment to minimize or eliminate work-related injuries.
Assessed risks and safety hazards and implemented plans to ensure personnel and equipment safety.
Worked with HR to ensure that the quality testing team is staffed, developed, and directed.
Ensured effective training and cross-training of employees.
Focused on preventing issues rather than just control, and driving the utilization of process management to deliver consistent results.
Identified and recommend process and equipment improvement opportunities, implemented projects.
Performed audits and ensured the use of analytics to identify risks, failures, and non-conformances, and ensuring that appropriate action is taken.
Experience
2-5 Years
Level
Executive
Education
BS
Quality Management Representative Resume
Objective : Quality Management Representative with certifications as an ASQ Certified Quality Engineer and Baxalta Lean Green Belt with eight years of experience in highly regulated cGMP environments. Core strengths in personnel management, statistical analysis of complex data, Operational Budget control, CAPA management and process improvements.
Skills : Lean Six Sigma, Auditing, Plasma Industry Regulations.
Description :
Managed the Quality infrastructure of a facility producing approximately 50,000 liters of source plasma per year.
Performed validation of equipment used in the process of source plasma production, and ensures that all manufacturing is performed according to international, domestic, and consignee requirements.
Utilized the DMAIC Kaizen process to improve systemic risks and improve bottom line results.
Managed nonconformances, corrective and preventative actions, and effectiveness assessments via TrackWise Systems.
Trained other Quality personnel in Baxter Quality Systems.
Reduced risk rating by 47% within first 90 days.
Continued reduction of risk rating by 86% within first two quarters.
Experience
2-5 Years
Level
Executive
Education
BS
Quality Management Representative Resume
Objective : Enterprising, forward-thinking strategist and hands-on change agent within Medical Device product industries. Process improvement driven offering more than 15 years of knowledge and expertise spanning from early technology to $40B Company Regulatory Compliance Quality Systems Deployment and Remediation Management.
Held quality review meetings with QLT's and members of management on a weekly basis.
Reviewed employee deviation reports and the associated corrective and preventative actions.
Reviewed standard operating procedures and submitted revision requests which promote continuous improvement in production and quality.
Ensured center compliance with FDA, state, local, and company specific regulations.
Reviewed all quality control, validation, training, calibration, maintenance, laboratory, packaging, inventory and shipment records to ensure compliance with internal standard operating procedures and external regulations.
Tracked deviations in standard operating procedures and policies through established mechanisms.
Experience
2-5 Years
Level
Executive
Education
Bachelor Of Science
Quality Management Representative Resume
Summary : Dedicated and innovative Quality Management Representative with extensive experience in quality teams with a special focus on records control. Strong leadership and problem-solving skills, can readily adapt to change, work independently, and exceed expectations.
Skills : Quality Management, Multitasking.
Description :
Provided Quality Assurance support to Newark and Fremont Environmental, Safety, and EMC testing facilities.
Implemented and maintained the Corporate Quality Policy Manual and Procedures to ensure audit readiness.
Facilitated internal and external audits and corrective actions to ensure compliance to the ISO standard.
Maintained facility readiness for external customer and regulatory audits.
Implemented Corporate Quality System throughout all the departments.
Performed internal and external audits.
Write and implement procedures to comply with company quality system.
Experience
10+ Years
Level
Senior
Education
BS In Liberal Arts Studies
Quality Management Representative Resume
Summary : Quality Management Representative professional with 14 years of Contract & Program Management experience. In her current position at T-Rex Corporation, she is responsible for providing end to end contractual support to the organization from program capture to closure. This includes managing all contractual matters from Non-Disclosure Agreements to Prime Contract to Subcontracts with suppliers.
Skills : Microsoft Office Suite, Autocad, Revit, As400.
Description :
Responsible for working with Senior Management to devise and establish the company's quality procedures, standards and specifications in order to achieve and maintain ISO 9001:2008 Certification.
Provided Quality Leadership to the business units in addition to interfacing with Customers and Suppliers.
Acted as the primary business quality owner for the Corrective/Preventive Action, Customer Complaint and Management of Change systems and coordinate Customer Information requests and Audits.
Drived quality improvement across all programs and projects by ensuring quality compliance and continuous improvements of both Quality Control & Quality Assurance processes Establish and implement key performance metrics (process capability, first pass quality, etc) for monitoring and measuring the program performance against customer requirements and implement an inspection process to support metrics data collection.
Coordinated with purchasing staff to establish quality requirements from external suppliers.
Responsible for conducting periodic audits and inspections to validate that the organization operates in a manner that meet international and national quality standards.
Defined quality procedures in conjunction with operating staff; setting up and maintaining controls and documentation procedures.
Experience
7-10 Years
Level
Management
Education
Masters In Business Administration
Quality Management Representative Resume
Headline : Quality Management Representative professional with a unique combination of experience working directly on the bench as well as exclusively in a quality assurance capacity. Extensive experience in areas of instrumental analysis and wet chemistry techniques, drug analysis and toxicology, research and development, clinical, forensics, healthcare, quality control (QC), quality assurance (QA), compliance monitoring, cGMP, cGLP, audits, inspections, safety and training.
Skills : Method Optimization, Validation And Development; Cell.
Description :
Observed laboratory procedures and reviewed records to ensure accuracy and compliance.
Tracked deviations and instituted corrective actions for any variances in procedures and policies.
Ensured SOPs were current and that required validation protocols were performed and reported.
Conducted quality assurance audits for critical control points and key elements.
Coordinated management review meetings.
Monitored performance by gathering relevant data and producing statistical reports; making suggestions for changes and improvements and how to implement them; using relevant quality tools and making sure managers and other staff understand how to improve the business.
Championed a portfolio of product quality improvement efforts that increase productivity and build a platform of competitiveness.
Experience
5-7 Years
Level
Executive
Education
Bachelor Of Science
Quality Management Representative Resume
Headline : Quality Management Representative With remarkable work experience in Finance and Accounting. Handles different functions such as Accounts Payable, Accounts Receivable, Payroll, Bookkeeping, and Cash Application. Acquired my corporate knowledge through training, seminars, and educational advancement, as well as through mentoring by the top management. Mainly responsible for the smooth flow of daily transactions in Finance and Accounting, Logistics, Purchasing and Warehouse Department.
Skills : Microsoft Office, Six Sigma Green Belt, Lead Internal Auditor, Lean Manufacturing, Leadership Training.
Description :
Coordinated ISO 9000 certification process in Cedar Rapids, Iowa and Idaho Falls, Idaho facilities.
Worked with team leaders to ensure that written procedures and instructions were completed.
Directed the internal audit program for the facility.
Worked with third party auditors to regularly assess the effectiveness of the ISO 9000 process and was responsible for corrective actions from the audit findings.
Planned, promoted and organized training activities related to Quality.
Maintained accredited calibration on test equipment for Newark Facility.
Conducted employee procedure audits for quality assurance purposes.
Experience
5-7 Years
Level
Executive
Education
Master Of Science
Quality Management Representative Resume
Summary : Over 30 years experience in manufacturing. Have worked as Behavioral Based Safety Facilitator, production supervisor, ISO 9000 manager, quality manager, production scheduler, laboratory technician and completed numerous cost savings and process improvement projects. Self-starter who is comfortable with multi-task situations and enjoys working in team setting with personnel at all levels of an organization.
Skills : Microsoft Office, Managing SKills.
Description :
Ensured that required validation protocols are performed and reported according to established guidelines.
Customers' industries ranged from pharmaceuticals to basic materials manufacturing.
Familiared with GMP, ISO, USP, and ACS standards, as well as the FDA and TTB regulatory agencies' requirements.
Reduced nonconformances per 1000 opportunities by 55% within first 90 days and sustained improvements.
Reduced cost by 63.41% in the first year through Value of Compliance program.
Prepared shipment paper work and boxing of samples/units.
Coordinated all breaks and schedules of both areas.
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