Quality Assurance Leader - Takasago - Harriman, NY
(2022-03)
QA Leader and Assistant Quality Director of the Quality Management System. Certified as an ISO 9001:2015 Internal Auditor.
- Lead the quality continuous improvements for all quality, production, and compounding processes
- Team leader for monitoring production output and producing high quality products on a day-to-day basis
- Work maintaining quality assurance procedures and methods to meet customer requirements
- Maintained the Quality Manual to ISO 9001:2015 standards for the company
- Conducted QA and cGMP training for all employees on an ongoing basis
- Lead investigations into all customer complaints, non-conformances with root cause and CAPA
- Extensive work with all WI's, SOP's (Standard Operating Procedures) and QMS documents
- Have conducted all internal audits as needed per plan
- Oversee quality inspections and investigate any OOS (Out of Spec) conditions
- Work includes review of all production KPI metrics for the year
- Can work in both office and production environments as needed
- Conducted Quality reviews and risk assessments including all regulatory audits as needed
Quality Assurance Manager - Accurate Forming - Hamburg, NJ
(2020-09 - 2022-03)
Manager of the Quality Management System, supplier, engineering, and EHS departments for a drawn metal stamping company.
- Reviewed and updated the company workstation instructions
- Lead the continuous quality improvements for all quality, production, engineering, and mechanical processes
- Team leader for monitoring production output and producing high quality products on a day-to-day basis
- Working with implementing strategic initiatives for all departments including PPAP, FMEA and Gage techniques
- Work maintaining quality assurance procedures and methods to meet customer requirements
- Maintained the ISO 9001:2015 standards for the company and leader of any ISO or internal audits
- SPC leader for key measurements of pharmaceutical, aerospace, and automotive products using minitab
- Conducted QA and cGMP training on an ongoing basis for FDA medical device regulations and audits
- Worked with evaluations of all non-conformances for the Department of Defense products
- Maintained all WI's, SOP's (Standard Operating Procedures) and QMS documents
- Work also consists of all CAPA reviews in a manufacturing environment and for customers
- Oversee quality inspectors in process inspections and investigate any OOS (Out of Spec) conditions
- Lead the QA team using lean, 8D, and 6 sigma type methodologies in new product introductions
- Work includes review of all production KPI metrics for each quarter
- Have the ability to work in both office and production environments as needed
- I worked as a safety manager for the company. This includes safety inspections and monthly safety meetings
- Comply with environmental regulations by having hazardous material waste training and certification
- Have DOT waste material training and certification
- Developed an emergency contingency plan for the company and commitment to OSHA
Manager of Quality Assurance - Ditron - Stormville, NY
(2020-03 - 2020-09)
Manager of the site QMS, Quality Management System, and all pharmaceutical production for a micro metal stamping company.
- Oversee six quality technicians, working with inspection and gauging equipment
- Extensive direct experience teaching and working with all production personnel daily
- Key leader working with ISO 9001:2015 Major contributor for customer satisfaction and delivery of all products
- Worked to maintain all process documents as needed for ISO 9001, including SOP's and Work Instructions
- Monitored all production to ensure high quality of products is maintained for medical and automotive parts
- Key leader for all 6-sigma process learning using minitab for verifications and process improvements
- Supported all KPI's for the plant, regulatory FDA requirements and safety reviews
- Continued support for Corrective and Preventative Actions for all Customer Complaints
- Overall SPC expert, collecting and analyzing data to report key trends and process capabilities
- Experience in teaching quality from requirements, including internal and external audits
- Worked to support production and process improvements throughout the manufacturing
Quality Assurance Manager - Hudson Valley Plastics - Pawling, NY
(2018 - 2020)
Quality Assurance Manager for an industrial plastic injection molding company.
- Experienced with ISO 9001:2015, maintenance, safety, and budgets in a manufacturing environment
- Working to maintain the company quality management system (QMS) and safety systems throughout the facility
- Extensive quality work includes dimensional gaging and visual defect identification with Injection molding products
- Director of the quality lab working with cGMP, HACCP, Hazardous Packaging and FDA regulations
- Knowledge of 21 CFR regulations, IOPP, ASQ, ISO 13485, QSR, QSIT
- Quality team leader for all products including cosmetics, pharmaceuticals, automotive and medical devices
- Involved in weekly MRB management meetings reporting all quality issues and continuous improvements
- Direct experience with Optical Comparators, Keyence visual measurement system and gauging tools
- Worked with engineering to assist in any mechanical equipment improvements
- Have strong knowledge in manufacturing operations and quality improvements from start to release of all products
- Worked setting up computer system upgrades for all workstations and writing SOP's and Work Instructions (WI)
- Supplied daily assistance with all quality inspections for automotive, pharmaceutical, medical and cosmetics parts
- Working on all certificates of compliance and COA's for all materials and products as needed for customer parts
- Lead company through all customer audits along with internal audits and safety audits
- Experienced with 6 sigma methods including quality 8D, FMEA, PPAP and 5 Why investigations
- Leader for the quality remediation strategy with cross functional teams, CAPA and consent decree agreements
- Have extensive SPC analysis and programming experience using Minitab and excel
Quality Engineer Leader - Materion - Brewster, NY
(2014 - 2018)
Quality Engineer Leader for a company producing metal alloy sputtering targets for worldwide markets.
- Extensive Quality Management work maintaining the QMS system, consistent with ISO9001 and AS9100
- Working on metal and oxide targets for hard disk drives, semiconductors, and other companies
- Experience with testing specifications and supplying a Certificate of Analysis (COA) with all products
- I reviewed any out of specifications and customer complaints as needed in our SAP system
- Developed the SPC computer programs that run and analyze temperature and vacuum data for the entire plant
- Supervising all clean room environment quality assurance inspectors for final packaging prior to shipment
- Team quality leader for all 5S, 8D, 6 sigma, SPC, DOE and FMEA analysis. Analysis reviewed in the MRB meetings for hard drive, semiconductor, and medical device issues with thin film coatings
- Have experience with SPC including process capability and process controls charting
- Attended weekly meetings to discuss statistical analysis data for current hardware to upper-level Vice President
- Leader of a worldwide SPC training program using Minitab statistical software and Infinity
- Experience in continuous improvements using lean methodologies with production employees
- Worked with machine shop employees managing the quality of all the products
- Continued work with all vendor's material, R&D and PE qualifications to support all customer requirements
- Establish reports that would highlight root causes and help fix defects in the metal materials for customers
- Managed the quality system along with all training needed for safety in a manufacturing setting
- Assisted the Plant Manager as needed in the day-to-day production
- Extensive Foundry experience
Staff Engineer - IBM Semiconductor Research and Development Center - Hopewell Junction, NY
(1985 - 2013)
Production/Manufacturing of Advanced SRAM Design and verification.
- Experienced in statistical analysis, yield analysis, trend analysis, problem solving and quality of semiconductors
- Extensive work with Six Sigma analysis programs, along with SPC analysis methodologies to improve the process
- Strong Design of Experiment (DOE) analysis
- I have strong computer skills with SAS programming experience in a UNIX environment as well
- Have lead project management skills in the semiconductor business to coach and mentor with very high-performance team members in a manufacturing environment
- Have strong Semiconductor process experience as a Staff Engineer
- Proficient at Defect/SEM reviews to identify yield detracting defects and work on increasing yield
- I have strong technical knowledge of many technologies and extensive quality control for process improvements
- Covered 6T FET SRAM bit cell characterization on 32nm, 22nm SRAM and 14nm transistor nodes
- Owned SRAM 6T FET Device characterization
