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Quality Director Resume Samples
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0-5 years of experience
Established and managed a total quality system that included management review, document control, training, customer feedback and complaints, internal audits, process improvement, and corrective/preventative action (CAPA) activities in one year. Created, implemented, and maintained all policies and procedures in compliance with cGMPs, OSHA, and HACCP standards at three different sites.
- Supervised, trained, and evaluated a staff of three QA technicians, and 4 department supervisors and three managers.
- Defined new standard operations procedures, company policies, and introduced and led the project management team to yield a 64% decrease in overall quality non-compliance.
- Monitored, analyzed, and redesigned workflow, processes, and procedures to resolve budget expenditures using root cause analysis and lean techniques.
- Completed Hazard Analysis and Critical Control Points (HACCP) training and implemented HACCP program at facility.
- Developed and implemented policies and procedures on safety and health to decrease non-compliance by 52%.
0-5 years of experience
Management Representative for ISO9000.
- Managed team of Process Engineers, Production Planners, Customer Technical Support, IT Dept. and Analytical Laboratory.
- Managed Supplier Quality programs.
- Developed and implemented plant wide Six Sigma program.
- Identified and eliminated top causes of slow moving inventory resulting in 35% defect reduction. Drove Product inventory reduction by 20% resulting in $1.5M savings.
- Achieved and maintained ISO9000 certification for 5 years
0-5 years of experience
Increased quality awareness and quality mindset across global organization.
- Developed and implemented balanced scorecard metrics and monthly reviews.
- Executed improved change control process.
- Provided quality tools training – Quality Systems, Change control, SPC, Statistics, FMEA.
- Achieved over 50% year over year improvements in Cost of Quality.
- Achieved over 20% improvements in customer complaint response cycle time.
6-10 years of experience
Established worldwide quality system for the Worldwide Digital Media Manufacturing division, encompassing 4 global sites, for all digital media products with over 20 international vendors. Led new product development cross-functional teams through Design for Six Sigma initiatives. Assessed performance, identified gaps and developed solutions. Developed and maintained quality process, guidelines and procedures used to deploy the Supplier Quality Process.
- Contributed to commercialization of 15 inkjet products ranked 1st and 2nd worldwide achieving two years’ customer complaint-free production. Utilized six sigma principles with worldwide teams, developing total customer value product specifications and achieving exemplary process capability results.
- Increased call center customer complaint resolution by 40%. Designed and implemented a standard data collection sheet capturing key product information that led to more immediate root cause identification and improved complaint resolution.
- Led cross-functional product improvement team, reducing supplier defect level 70%, with $500K productivity improvement. Established on-going QA process, ensuring product quality.
- Reduced customer complaints and increased customer satisfaction to less than 3 defects per million units sold. Standardized RCA/CAPA processes and introduced QAS to maintain improvements.
- Established supplier quality process achieving double digit productivity and six sigma quality for key vendors, rated best in class and adopted company-wide. Led multi-functional team, identifying quality measurements. Developed supplier quality agreement instituting quality, on time delivery and productivity metrics acceptable to both parties.
6-10 years of experience
Established worldwide quality system for the Digital Media Manufacturing division, encompassing 4 global sites, for all digital media products with over 20 international vendors. Led new product development cross-functional teams through Design for Six Sigma initiatives. Assessed performance, identified gaps and developed solutions. Developed and maintained quality process, guidelines, and procedures used to deploy the Supplier Quality Process.
- Contributed to commercialization of 15 inkjet products ranked 1st and 2nd worldwide achieving 2 years’ customer complaint-free production. Utilized Six Sigma principles with worldwide teams, developing total customer value product specifications and achieving exemplary process capability results.
- Increased call center customer complaint resolution by 40% by designing and implementing standard data collection sheet capturing key product information that led to more immediate root cause identification and improved complaint resolution.
- Led cross-functional product improvement team, reducing supplier defect level 70%, with $500K productivity improvement. Established on-going QA process, ensuring product quality.
- Reduced customer complaints and increased customer satisfaction to less than 3 defects per million units sold using standardized RCA / CAPA processes and introduced QAS to maintain improvements.
- Established supplier quality process achieving double digit productivity and Six Sigma quality for key vendors, rated best in class and adopted company-wide.
6-10 years of experience
Developed and managed a multiple stamping plant team of 17 quality managers and two staff quality managers that supported delivery of components to the assembly plant operations. Responsibilities ranged from resource coordination, quality systems, supplier quality assurance management, appearance and dimensional verifications to implementation of measurement systems, and issues resolution.
- Created a manager’s scorecard performance review of the plants’ performances which improved consistency and achieved best of the best.
- Initiated quality readiness reviews assuring products and processes were progressing through the vehicle development process with corresponding achievement in development.
- Developed and deployed a quality verification station process to the stamping operations assuring quick feedback to the production teams.
- Created and led a best practices sharing process to level up all plants achieving best of the best/lean.
- Implemented urgent response system that supported assembly plants and disruptions learning.
- Established a common repair process that applied to all stamping and assembly plants.
- QS and ISO certification programs initiated and maintained
0-5 years of experience
Handle all QA/QC activities, regulatory compliance and R&D functions for a production facility generating 2.5 million units per day. Have full departmental P&L responsibility over personnel, equipment and contract operations. Provide the main contract customer support interface. Develop and implement policies, procedures and drive cost of quality initiatives. Coordinate with and represent facility for FDA regulated inspections. Execute design control, scale up, validation and optimization projects. Develop specifications and qualify materials and vendors.
- Revamped entire quality system to meet 21 CFR 210-211 cGMP requirements.
- Expanded manufacturing portfolio by introducing FDA registered product lines.
- Reduced nonconforming / rework activities by over 50% in one year time frame.
- Utilized “point of origin” quality deployment to reduce quality staff by 40% and reduce departmental costs by over 25%.
6-10 years of experience
Established worldwide quality system for the Worldwide Digital Media Manufacturing division, encompassing 4 global sites, for all digital media products with over 20 international vendors. Led new product development cross-functional teams through Design for Six Sigma initiatives. Assessed performance, identified gaps and developed solutions. Developed and maintained quality process, guidelines and procedures used to deploy the Supplier Quality Process.
- Contributed to commercialization of 15 inkjet products ranked 1st and 2nd worldwide achieving two years’ customer complaint-free production. Utilized six sigma principles with worldwide teams, developing total customer value product specifications and achieving exemplary process capability results.
- Increased call center customer complaint resolution by 40%. Designed and implemented a standard data collection sheet capturing key product information that led to more immediate root cause identification and improved complaint resolution.
- Led cross-functional product improvement team, reducing supplier defect level 70%, with $500K productivity improvement. Established on-going QA process, ensuring product quality.
- Reduced customer complaints and increased customer satisfaction to less than 3 defects per million units sold. Standardized RCA/CAPA processes and introduced QAS to maintain improvements.
- Established supplier quality process achieving double digit productivity and six sigma quality for key vendors, rated best in class and adopted company-wide. Led multi-functional team, identifying quality measurements. Developed supplier quality agreement instituting quality, on time delivery and productivity metrics acceptable to both parties.
0-5 years of experience
Knitting through Dye and Finishing – Mechanical and Wet
- Directed QA process for the [company name], which produced numerous knit textiles including Polartec(TM) and Polar-Fleece(TM) fabrics. Realized a 25% reduction in seconds from 1994 to 1998
- Reported to Divisional Director
- Developed and implemented Quality Control procedures for supplier’s quality, manufacturing (circular knit through dyeing and finishing) and inspection processes. Also interacted with customers on Quality Assurance issues
- Managed Quality Assurance staff of 24 associates (QA and process engineers) including internal testing labs.
- Coordinated QA efforts with commissioned dye/finish facilities following the major fire that destroyed most of Malden Mills manufacturing capability in December 1995
- Involved with training Malden Management associates in TQM, SQC/SPC, FMEA, DOE and Cause Analysis Techniques
0-5 years of experience
Maintain aerospace quality system- NADCAP (National Aerospace and Defense Contractors Accreditation Program)
- Led investigations of new chemistries resulting in $25000 annual savings
- Eliminated three main failure modes for internal rework
- Gained first in the nation approval for zinc-nickel plating from Lockheed Martin
- Created inventory database for purchasing raw materials
0-5 years of experience
Managed Engineers, IT Professionals & Various Techs
- Designed New Product Lines as follows; Electro-Mechanical Module, New Engine and Laser Instruments
- Responsible for Coatings, Castings, Forgings, Welding, Heat Treat, Plastic, CNC Machining & Screw Machines
- Turned around Company’s Position from the Bottom of the Score Cards to Top of the Score Cards
- Achieved 100% Perfect ISO-9001 – 2000 Certification with major Global Registrar
- Replaced substandard suppliers and reduced incoming rejects by 90%
- Provided Technical Support to Customers
- Qualified Suppliers based on TQM
0-5 years of experience
Directed a team of quality professionals supporting manufacturing operations and raw material approvals for the light food metal packaging industry.
- Reduced division COPQ by $1.5MM or about 20% in one year.
- Generated raw material cost reductions of $1-2MM annually.
- Developed a set of quality metrics to track operational performance and identify/prioritize areas for improvements.
- Directed problem solving projects involving complex technical excursions that had significant customer impacts of >$1.5MM.
- Directed improvement projects focused on manufacturing defect reduction.
0-5 years of experience
Managed Engineers, IT Professionals & Various Techs
- Designed New Product Lines as follows; Electro-Mechanical Module, New Engine and Laser Instruments
- Responsible for Castings, Forgings, Welding, Heat Treat, Plastic, CNC Machining & Screw Machines
- Turned around Company’s Position from the Bottom of the Score Cards to Top of the Score Cards
- Achieved 100% Perfect ISO-9001 – 2000 Certification with major Global Registrar
- Replaced substandard suppliers and reduced incoming rejects by 90%
- Provided Technical Support to Customers
- Qualified Suppliers
0-5 years of experience
A shareholder of 15% of the company.
- Ensure that the company follows all certification guidelines.
- Wrote the Medical Device Quality System Manual for GMP Certification.
- Assisted the General Manager and CEO; oversaw staff of 50.
- Complete involvement in management, finances, marketing, customer services, and production.
- Utilized Excel modeling to analyzed daily, monthly, and yearly reports across all departments.
- Attend and travel for lectures, meetings, and conferences whether local or abroad.
- Served as a point of contact for potential and existing clients; managed Clients requests and assisted on their accounts.
0-5 years of experience
Responsible for ensuring customer quality standards are met, while maintaining low quality risk. Communications to senior staff (USA and overseas) of monthly quality status, as well as customer metrics/issues. Direct customer contact regarding quality issues. Managed department of 15 Quality Engineers, and 6 Customer Plant Quality Engineers.
- Develop corporate quality metrics, making visible trends/data to support department and company directions.
- Created budget and accounting tracking procedures and practices. Reduced Budget 12% ’00’FY. Initiated cost recovery system, recovering $240K from other ALPS divisions.
- Developed customer support network for immediate technical contact for several customer sites in the USA and Mexico. Contracted with 8 local representatives at customer sites, which improved service and lowered customer claims.
- Developed process approval and product readiness programs for the Mexican assembly plant enabling definition of launch risk prior to production.
- Implemented Customer Quality reporting systems and communications for GM, DaimlerChrysler, Ford, Nissan, Honda, Toyota, and other major customers.
- Developed and implemented a warranty part analysis, reporting and customer feedback system.
- Hands on leader for customer issues, problem solving (8D, 7Step, 5 phase, HTR, etc), PPAP preparation, APQP preparation, and FSS meeting preparation supporting the total team effort.
- Track program management timing vs. Quality deliverables. Monitor all program issues, ensuring compliance to program timing requirements.
0-5 years of experience
Designed, developed and documented the company’s Quality System including Work Instructions for the transition to ISO 13485:2003 and ISO 9001:2000.
- Performed internal audits to monitor compliance to standards, policies, procedures and timelines.
- Facilitated during audits by third party auditors and Notified Bodies.
- Developed metrics and generated reports for supplier evaluation.
- Documented and submitted requirements for all product lines to Notified Bodies for CE marking application.
- Prepared and submitted documents for US 510ks and Canadian Medical Device Licenses as well as other countries.
- Ensured all product documentations are in compliance to FDA and EU regulations.
- Compiled and maintained Technical Files for all product lines.
- Arranged overall logistics in the supply chain from purchasing to end-user distribution.
- Ensured that all products for international shipments comply with the standards and are supported by appropriate documents.
0-5 years of experience
Developed new OTC birth control product and administrated product development from R&D phase to market distribution (complete product realization)
- Formulated, directed and implemented all quality-related systems and procedures, ensuring regulatory compliance throughout the organization
- Assisted in developing, establishing, validating, and troubleshooting analytical test methods and procedures for all products
- Conducted and hosted audits for vendors and relevant regulatory affairs, ensuring renewed licenses on all regulatory fronts
- Responsible for training of employees in all departments
0-5 years of experience
Responsible for telecommunications qualification and reliability requirements, business systems, quality culture growth over multiple sites. Managed $500K departmental budget within a $30M division revenue stream.
- Successful qualification for telecommunications optical materials.
- Member of International Telecommunications Standards committee.
- Received president’s award for leading employee initiated continuous improvement activity.
- Managed high-volume production increase from 100 to over 60,000 optical components /week.
10+ years of experience
Start up of the facility. Direction and leadership of the Quality Control and Quality Assurance operations as well as the process validation and equipment qualification teams. Developed and implemented the quality systems, as well as the policies and procedures. Provided support to the manufacturing and packaging operations facilitating the technical transfer of 32 families of products.
- Leaded and managed the technology transfer process for multiple families of products, as well as their respective analytical methods.
- Served as main escort for FDA and corporate auditors.
- Assigned to work at India in the evaluation and compilation of the documentation required for the filing of two new products in the U.S. market. Both products were approved by FDA.
0-5 years of experience
- Instituted site level KPI’s to pulse organization and reported progress at monthly contract review meetings.
- Responsible for overseeing implementation and operations of the quality management system across 16 contracts.
- Developed and conducted root cause analysis training for Executive Staff.
- Managed P&L for Quality department across contracts to ensure allotted hours remain within budget.
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Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
