999 Main Street, Any Town, NY 99999
detailed, organized, focused professional with a unique ability to successfully manage multiple quality projects simultaneously energetic, motivated self-starter with a strong sense of dedication and support to the mission Goal oriented and well-developed interpersonal communication skills to work effectively and productively with team members, people from diverse professional and cultural backgrounds.
- Excellent Customer Service Skills
- Information & Referral
- Community Outreach
- Quality Management
- Internal and External Audits
- Quality Control & Quality Assurance
- Receiving Inspection and Materials
- Ability to Multi Tasks
- PowerPoint Presentation
- Bilingual English/Spanish
ABC Inc., Any Town, NY 09/2009 – 01/2010 (4 months)
- Participate in QA process, developed include Flow Charts and Control Plans.
- Develop the required documentation for each specific customer requirements.
- Maintain customer contacts by being proactive and reactive to all customer concerns for internal and external customers.
- Perform capability studies as required.
- Participated in internal auditing and layered audits.
XYZ Corp., Any Town, NY 01/1997 – 02/2009 (12 years)
- Tested constructions and established parameters for new equipment.
- Researched, tested, and analyzed new equipments.
- Developed, tested and established processing parameters for environmentally friendly .
BCD Inc., Any Town, NY 12/1983 – 12/1996 (13 years)
- Developed, implemented, and provided training.
- Participate on multiple Project Teams as a Quality Engineering Representative, ensuring compliance to regulatory standards and providing input into the project design input requirements and product development quality plans.
- Proficient in application of Design Controls, Good Manufacturing Practices and ISO.
- Developed and validated various test methods.
- Established In-process Production and Final QA Inspections plans.
- Provided technical guidance to Quality Technicians and Inspectors.
- Utilized statistical methods, such as, process capability data analysis, statistical process control (SPC), and scientific sample size selection to ensure processes capability and repeatability and to determine statistically valid sampling plans.
- Provided technical support to solve quality problems in product development and manufacturing.
- Performed Design of Experiments to support process optimization.
- Participated and conducted the design transfer and design review aspects of design control for QE input / support.
- Conducted Internal Audits per Internal SOP, QSR Regulations, and ISO requirements.
- Managed and Mentored Quality Engineer Interns.
- Developed and reviewed various protocols for Process Qualification, Design Verifications and Validations, Stability, Installation Qualifications, Operational Qualifications, and master validation plans
- Developed, Reviewed, and Managed Risk Assessments including Intended Use/Hazard Analysis, PFMEA, and DFMEA.
- Complete Complaint Investigations by analyzing returned.
- Identified, investigated and determined final disposition of non-conformances.
- Lead Continuous Improvement team from various disciples to improve current process verification procedures.
- knowledge in Stat graphics, WordPerfect, Word, PowerPoint, Excel.
- Arizona State University, Tempe
- Master of Business Admin & Technology Management.