Fernando Sanchez Email & Phone Number

San Diego, CA, US

Poway, California, US

* Strategic management of the Quality and Regulatory operations of 2 domestic and 1 overseas site* Directed the development and implementation of a comprehensive internal Quality Audit strategy across multiple domestic and overseas sites, enhancing audit efficiency by 16% and ensuring compliance with global regulations* Implemented risk assessment and.

San Diego, California, US

• Deploy revised design control processes/procedures incorporating software, human factors, and electrical/mechanical disciplines, while executing early clinical, marketing, regulatory, manufacturing, and quality.
• Decreased launch of new products by four months and product failures by 14% via implementing Lean Sigma methodology throughout the Design, manufacturing, and shipping processes.
• Established Quality Assurance team overseeing full medical device lifecycle from customer/clinical input via design, manufacturing, post-market surveillance, and end-of-life.
• Met requirements of ISO 13485, MDSAP, CFR 820, and EUMDR by rewriting quality management system with functional department heads.
• Steered Regulatory Affairs team with successful submission in the FDA, EUMDR, MDSAP and Middle East markets.
• Reduced final inspection timelines by 68%, while increasing defect detection and documentation.

Malvern, PA, US

• Administered quality and regulatory professionals across three sites in United States. Developed state-of-the-art CAPA review board, NCR, and SCAR practices, increasing availability of relevant improvement data and.
• Met regulatory requirements of design, manufacturing, distribution, and post-market surveillance operations, while performing as key liaison between regulatory bodies and operating divisions within company.
• Acquired drastic 70% reduction of external findings and finding severity, while overseeing internal audit program increasing number of internally qualified auditors.
• Enhanced 43% efficiency by initiating and leading early quality design assurance involvement on all R&D (hardware/software) projects.
• Reduced six-month time-to-market KPI for new products and four weeks for redesign projects by executing Lean Sigma methodology to design and development procedures, while designing efficient hardware/software design.
• Ensured continued and improved compliance with MDSAP, EUMDR, QSR, ISO 13485:2016, and 14971:2019 standards with newly created regulatory affairs department.

Franklin Lakes, New Jersey, US

• Served as infusion pumps R&D quality engineer for both US and International products. Conducted Assurance Case and 510K preparation for FDA review and approval of medical devices. Acted as the Quality Engineering –.
• Prepared and presented the company's first Assurance Case that the FDA accepted with no revisions or denials. FDA used this Assurance Case submission as an example to the infusion pump industry.
• Implemented the company's new Assurance Case methodology, training five peers to assist in future AC - 510K submissions.
• Performed risk management per 14971 for US and International infusion devices.
• Coordinated the transition from 14971:2007 to 14971:2012. Sourced, procured, and validated the new risk management software suite.
• Provided thoughtful application of the quality management system to all stages of product design for complex electro-mechanical infusion pumps with a heavy emphasis on software development. Creative problem solving and.

Carlsbad, US

1. Implementation of the ISO 13485:2003 and AS9100 rev C Quality Management Systems with an emphasis on First Pass Yield improvement, product development and organizational excellence. 2. Management representative and point of contact for compliance to CFR 820, 510K submissions, and regulatory audits from the FDA, California Food and Drug branch with an.

Poway, California, US

 Wrote all required QMS documentation and achieved ISO 9001:2000 certification in 6 months with no findings or observations during the initial assessment. Implemented formal incoming inspection techniques, introduced the National Instruments Vision Builder automatic inspection software, and planned and implemented in process and FQA procedures, resulting.

Vista, California, US

Created a team-oriented environment that enabled the incoming inspection function to reduce inspection time from an average of 20 days down to ~6 days.  Administrated the factory acceptance function by ensuring that the visiting customer would find the tested equipment in an acceptable stage. Also coordinated the customer complaints/investigation of.

Santa Ana, CA, US

Santa Ana, CA, US

Master'S Degree, Business Administration And Management, General

Affiliate Finance And Economy Program, Finance, General

Bachelor'S Degree, Business Administration And Management, General