Quality Engineer /Manager

OSCAR G. SALDANA

**** *. ******** ****** *******, CA 95358

209-***-**** *************@*****.***

QUALITY ASSURANCE MANAGER/QUALITY ENGINEER

Highly accomplished professional with proficient knowledge of QA and Regulatory compliance, life-cycle management, standard procedures and policies, and process improvement. Solid communication and presentation abilities and skilled in articulating innovative quality solutions for maximum performance. Adept at reducing cost by driving inefficiencies and coordinating project development efforts. Knowledgeable in medical device industry standards as applicable to U.S and EU. Recognized for introducing effective training programs and capacity to steer consensus among core business disciplines with diverse visions.

Operational Streamlining Leadership Quality Engineering Lean Manufacturing

Analysis Continuous Quality Improvement Project Management CAPA 21 CFR 820

ISO 9001 ISO 13485 Council Directive 93/42/EEC (MDD) CE Mark Strategic Planning Test Operations RAPS Member

PROFESSIONAL EXPERIENCE

SI-BONE, INC., San Jose, CA 07/2009-01/2011

Quality Assurance Manager/Quality Engineer

Responsible for managing and implementing the quality function, CAPA System, supporting R&D/Engineering, Operations, Regulatory Affairs, Clinical Research and Operations, Marketing, and Human Resources/Training. Ensuring the company’s operations, policies, product development programs, and post market activities are in compliance with applicable standards and regulations. Appointed as Management Representative under ISO 13485.

• Instrumental in achieving ISO 13485 certification and CE Mark enabling domestic and international marketing of medical device.

• Established the necessary QMS systems to support company quality, including procedures, documentation, internal and external audits, and new employee training.

• Ensured product conforms to specification.

• Ensured control of all product and product related materials are established.

• Responsible for investigating CAPA for root cause and implementing changes as appropriate.

• Instrumental in a successful audit by the CDPH.

• Met goals set for QA department.

TRIPLE RING TECHNOLOGIES, INC., Newark, CA 2004-2009

Quality Assurance Manager

Inspect and verify product and test processes, and manufacturing/engineering documents to ensure compliance with FDA, ISO, and GMP requirements. Draft and communicate SOP and work instruction for quality and production procedures. Responsible for managing CAPA System. Managed a team of 12 Inspectors. Appointed as main contact for technical issues and served in similar contract positions for Xoft, Inc. and Supplier Link Services.

• Instrumental in achieving ISO certification by collaborating on the development of a form-based quality management system tailored for service providers.

• Improved inspection time and quality by reviewing and enhancing existing processes and procedures

• Consistently exceeded goals for medical device industry QA department.

• Ensured 510K approval by effectively managing assembly, testing and documentation of Beta systems for full compliance and implementation of new product transition from inception to completion.

• Championed the development and launch of a single source document service for Engineering Change Order process that allowed online access for personnel use.

ACCURAY, Sunnyvale, CA 2000-2004

Quality Assurance Manager/Quality Engineer

Provided leadership and support for a six personnel QA team. Formulated clear and concise protocols that enhanced operations and secured FDA, state, and ISO quality standards compliance. Ensured safety and quality by effectively managing the quality system, CAPA System, tool calibration processes, Maintaining training records and establishing preventative measures.

• Improved production 300%, enhanced inspection phases, and reduced production rejection rates 64% by developing a Supplier Quality Standards and Evaluation System.

• Consistently exceeded corporate production, quality, and management goals by proposing process changes utilizing extensive knowledge in engineering and manufacturing processes to streamline operations.

• Coordinated MRB for engineering, design, and quality system changes.

• Responsible for investigating CAPA for root cause and implementing changes as appropriate.

• Instrumental in a successful audit by FDA and CDPH.

• Instrumental in achieving ISO 13485 certification.

INTEVAC, Santa Clara, CA 1992-2000

Quality Assurance/Manufacturing Engineer

Managed QA department and analyzed and maintained compliance on all production equipment. Responsible for incoming and fabrication inspection including first article, cleaning, plating and electro polishing for ultra high vacuum applications.

• Improved workflow and overall departmental image by restructuring QA department.

• Managed calibration process of inspection equipment.

• Coordinated MRB for engineering, design, and quality system changes.

• Reviewed engineering drawings for functionality and assisted in making changes.

• Enhanced QA inspection testing times and increased accuracy for data printouts by developing and launching Coordinate Measuring Machine (CMM) Programs for inspection of vacuum chambers and machined product.

CAREER DEVELOPMENT

Coordinate Measuring Technology Fundamentals Certification

Geometric Dimensioning and Tolerance Certification, Multi Metrics, Sunnyvale, CA

Quality Control Technician Certification, Lockheed Missiles and Space, Sunnyvale, CA

ASQ Quality System Regulation Certification

48 credits completed for aa degree

20+ years experience in the quality industry

TECHNICAL KNOWLEDGE

• Microsoft Windows

• Word

• Excel

• PowerPoint

• Outlook

• Access

• Visio

• Solidworks

• MRP

• Solidworks

• PDMLink

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