A Quality Systems Specialist is responsible for supporting and providing oversight of the company’s quality management systems. The job description entails ensuring the existing systems are implemented and followed and to improve the quality system as applicable. The position responsibilities are listed on the Quality Systems Specialist Resume as – evaluating, developing, and updating and maintaining quality policies, and procedures following industry standards; providing quality expertise and guidance to the site personnel on quality system policies and procedures; coaching site staff, performing self-audits and developing action plans; leading and managing quality system improvements; and providing support to the department and site as needed.
The most sought-after skills include – prior quality systems or auditing experience; familiarity with change control documentation systems; CAPA documentation systems experience; and knowledge of all aspects of industry device operations; and auditing experience. The minimum education required includes a degree in engineering stream.
Headline : Talented Quality Leader with Quality/Compliance experience in compiling regulatory submissions, leading project teams, improving Quality Systems, and conducting audits/investigations. Well versed in creatively managing Cost of Quality (CoQ) reduction initiatives.
Skills : Managing, Training, Communication.
Description :
Reviewed proposals regulatory, program, and Department of Defense US Government customer (DCMA) requirements to ensure early quality involvement in program development.
Prepared and maintained Quality directives, policies, processes, procedures, and metrics to assure program, contract, external customer, regulatory requirements, international standards, and working agreements are deployed.
Worked with Aviation Intermediate Maintenance (AVIM), and Aviation Unit Maintenance (AVUM) tasks.
Conducted research, to continuously improve process capability.
Integrated Operations; developed scope, planned and lead hardware, software, and system operation level audits to maintain compliance with Quality Management Standards AS9100.
Worked with Integrated Quality Data System (IQDS), Interactive Electronic Technical Manual (IETM) Maintain GSE licenses, operator permits, and certifications as required per Boeing and Navy standards.
Planned, documented, and reported audit and assessment results using (EPES), perform follow-up audits and assessments on findings.
Experience
5-7 Years
Level
Executive
Education
GED
Quality Systems Specialist Resume
Objective : As a Quality System Specialist, responsible for Controlling and maintaining the Quality Records Management System (QRMS) and Quality Stamp Control system. and also Maintaining site and offsite inventory control for Quality Stamps.
Worked directly with Management and Executives to achieve and maintain compliance with Military, Customer, and Regulatory Aerospace requirements.
Monitored external QMS requirements (customer or supplier) and ensure appropriate gap analysis against the Division QMS.
Performed data analysis and provide recommendations to Management and Executives to achieve new customer approvals.
Orchestrated preparatory activities for all departments for Military, Customer, FAA, Nadcap and AS9100 audits.
Ensured Heat Treat, Chemical Processing, Welding, and NDT departments maintain strict compliance with requirements as flowed down by internal procedure.
Interpreted customer drawing and specification revisions and implemented planning and internal specification revisions to maintain compliance.
Prepared specifications and planning operations to ensure strict compliance to standards and customer requirements.
Experience
2-5 Years
Level
Junior
Education
High School Diploma
Quality Systems Specialist Resume
Headline : Seeking a Quality System Specialist, responsible for Reducing downtime of equipment by performing preventive and predictive maintenance on all equipment. Experience in Performing problem-solving analysis and risk assessment on all products that failed to meet safety or sensory standards.
Skills : Microsoft Office, Minitab, SQC Pack, Trackwise.
Description :
Maintained processes and procedures to ensure compliance with internal and external requirements.
Provided compliance support for manufacturing, R&D, Quality Assurance, and Operations to assure regulatory compliance and appropriate business planning.
Managed creation, review, revision, approval, release, and implementation of change orders within the Document Control System and provide companywide training.
Reviewed and approved the final release of products and bulk material, ensure they meet established specifications and customer requirements, procedures are followed, and records are accurate.
Addressed issues and nonconformities, where necessary.
Served as Internal Auditor, generate corrective action plans, and establish a structure to review audit findings.
Ensured effective remedial measures are agreed upon, implemented, and documented.
Experience
5-7 Years
Level
Executive
Education
High School Diploma
Quality Systems Specialist Resume
Objective : To obtain a Quality System Specialist with 3 years of experience in Developing strong, collaborative relationships with above site partners and suppliers to help facilitate completion of Quality System activities.
Skills : MS Office, Managing, Assisting.
Description :
Assisted in the preparation of records prior to and during regulatory inspections.
Actively participated in any clerical support needed to establish compliance.
Maintained a tracking system for all quality system reports, forms, and other applicable records and spreadsheets.
Assessed for deviation error codes and determine investigation categories.
Prepared statistical data for review for the Quality Assurance Management meetings.
Maintained current Federal and State licenses, accreditations, and registration files.
Continual maintained of the Quality System procedures with the management of the Document Control system.
Experience
2-5 Years
Level
Executive
Education
Bachelor Of Science
Quality Systems Specialist Resume
Objective : Quality System Specialist with 5 years of experience in Following-up to ensure process non-conformance situations are fully resolved and their resolutions are properly documented. Responsible for Collecting quality metrics data related to corrective actions, complaints, operational changes, and process capability.
Skills : Designing, MS Office, Collaborating.
Description :
Responsible for improving or developing processes to improve quality and to reduce resource commitments.
Created and maintained key Quality performance measurements for QA leadership.
Established CIMA's original 21part11 procedures and gap analysis.
Assisted the Validations department with computer and network validations.
Installed laboratory equipment and validated per SOPs, GMP's, and cfr21part11 requirements.
Redesigned incoming raw material flow.
Modified and created new procedures to reduce overall work reduction of 40% for QC raw materials group and over 90% for packaging components.
Experience
2-5 Years
Level
Executive
Education
Bachelor Of Science
Quality Systems Specialist Resume
Objective : Quality Systems Specialist with 6 years of experience in Ensuring that all product shipments meet customer requirements by, conducting final product visual inspections and reviewing analytical results.
Wrote, updated, proofed, and audited documents that reflect current processes to meet ISO 9001 certification standards.
Worked required harmonizing CIMA testing with ANSI standards and several vendors/suppliers to establish sampling at the time of manufacture instead of receiving at CIMA.
Significantly reduced supply-chain lead times, shipping expenses, and dramatically improved Quality and Reliability.
Participated in defining and revising policies and procedures related to Quality Assurance and Document Control.
Successfully maintained SOP development cycles for all corporate standard operating procedures.
Led and/or supported CAPA and NCR investigations and assist management in creating measurable data for periodic reviews of Quality System.
Compiled data and provides recommendations for material review disposition.
Experience
2-5 Years
Level
Executive
Education
G.E.D
Quality Systems Specialist Resume
Objective : To obtain a Quality System Specialist with 4+ years of experience in Assisting in investigations and determine disposition for internal/external reported defects and develop a corrective action plan.
Skills : Designing, Analyzing, Communication.
Description :
Prepared and maintained quality directives, policies, processes, procedures, and metrics for the Boeing 787 Program to assure program, contract, customer regulatory requirements, international standards, and working agreements are deployed.
Analyzed aircraft manufacturing process data, metrics, models, and flows to identify the root cause of manufacturing non-conformances on the Boeing 787.
Created a Process Improvement tracking system for Boeing's 787 manufacturing line.
Designed and implemented a Predictive Analytics application that analyzed data gathered on recently performed aircraft assembly tasks and generated statistics on the likelihood of successful completion of each individual task when performed during future aircraft assembly.
Set up 787 Quality Visibility team's reporting database servers and transitioned databases containing data critical to the team's success from MS Access to SQL Server.
Designed and implemented subject matter data marts used to consolidate data from a variety of different data sources (Excel, Access, text files, Teradata) in order for the team to present consistent, reliable metrics for the 787 Program Senior Management team.
Collaborated with internal and consultants to manage project schedules, executions, and deliverables Prepare audit room, audit documentation, and as SME interact with external auditors.
Experience
2-5 Years
Level
Executive
Education
G.E.D
Quality Systems Specialist Resume
Objective : Seeking a Quality Systems Specialist, responsible for Developing and executing multiple Food Safety-focused training sessions to mitigate incidences and improve the food safety culture. Experience in Developing a new process for creating product specifications for new products and improve specifications for workflow for active products to reduce defects, increase efficiency, and save on production costs.
Skills : Quality Management, Operations Management, Training & Development.
Description :
Performed microbiological testing and safety auditing to ensure company compliance with USDA and FDA standards.
Collected a sampling of production material for all testing needs.
Determined specifications necessary and required by customers as well as industry compliance standards.
Implemented Quality Control standards in all testing and production environments to ensure quality product was being delivered to all customers.
Championed the development of a new manufacturing area auditing system and analytical workflow.
Reduced waste and rework of material after implementation.
Authored a maintenance plan for laboratory analytical equipment.
Experience
2-5 Years
Level
Executive
Education
Master of Science
Quality Systems Specialist Resume
Objective : Quality Systems Specialist with 2 years of experience in Performing compliance reviews and managed cycles of the revisions for all local standard operating procedures Managed metrics surrounding SOPs.
Skills : Inventory Management, Six Sigma, Data Analysis, Strategy Planning, Supply Chain Management, Process Improvements, System Design, Microsoft Office, Microsoft Access, SQL, Microsoft Visio, Microsoft Project.
Description :
Developed and revised SOP's to ensure the best operating practices were utilized throughout the production process and compliance to standards were maintained resulting in improved customer satisfaction.
Developed and implemented a defect tracking system utilizing MSAccess with multi-level security to capture non-conformance trends & costs for analysis.
Designed and implemented a Cost of Quality system, now being used throughout US facilities, to capture non-conformance and conformance costs for the analysis of the impact to bottom-line budget performance and plant goals.
Investigated and provided report outs to customers for all complaints.
Resolved issues in a timely manner to maintain or increase customer satisfaction.
Analyzed non-conformance trends and costs to build corrective/preventive action plans to decrease the frequency and cost of non-conformances.
Developed and implemented a New Hire Training Program to ensure consistent quality performance throughout the plant.
Experience
2-5 Years
Level
Executive
Education
GED
Quality Systems Specialist Resume
Objective : As a Quality Systems Specialist, Responsible for reviewing quality data records and serialization processes to ensure accuracy according to Boeing standards and procedures.
Skills : Microsoft Office, Training & Development, Organizational Development, Written Communication, Instructor, Typing, Communications.
Description :
Assisted in review of proposals, contracts, regulatory, program, and customer requirements to prepare quality assurance plans and tests for hardware and software products, processes, and services.
Maintained Quality directives, policies, processes, procedures, and metrics to assure program, contract, customer, regulatory requirements, international standards, and working agreements are deployed using established procedures.
Collected and verified data to support the identification of root cause routine problems.
Provided ideas and concepts for corrective action development.
Supported quality source selection and process reviews of suppliers' ability to meet program quality requirements.
Assisted with hardware, software, and system-level audits to determine compliance with quality management system standards, configuration assurance, related business, regulatory, and customer requirements.
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