Fred Lopez

About Fred Lopez

Results driven strategic leader with expertise in multiple regulated industries, including companies that manufacture & design; Medical Devices, Pharmaceuticals, Bioactive Combination Devices & Tissue Products, Aerospace, Defense, and Nutraceuticals. Hands-on leader adept at driving business improvements that translate into bottom-line results, improved business processes & systems, and customer satisfaction. Leverages Six Sigma and Lean tools that drive efficiencies and effectiveness.Excellent track record implementing business processes, Quality Systems, organizational development, change management, and leadership development of high performing leaders. I use inclusive methods that instills ownership and sustainability. Technical expertise in creating Quality Systems, new product development, design transfer, and complex manufacturing operations, within highly regulated industries.

Experience

1. President

   Strategic Consulting Solutions Llc

   Feb 2011 — Present · Austin, TX, US

   Founded a consulting firm for the biotechnology industries with expertise in medical devices, combination devices, tissue, pharmaceuticals, and OTC. Established a book of clients ranging from start-ups and mid-size companies to F500 and large global organizations in Europe, the UK, the Middle East, the US, and Caribbean locations.• Sourced and recruited 200+ resources to provide temporary, hands-on support for technical andleadership roles, including QA/QE, RA, Design Engineering, Mfg Engineering, Process Validation, etc.• Drove clients business growth by developing strategies and action plans related to productperformance trending/reporting, product/process investigations, risk assessments, remediation, andregulatory escalations.• Hired and supported the career growth of XX interns by creating an engineering internship and trainingprogram through partnerships with strategically located Universities and medical device clients.• Developed a unique project planning model for clients to calculate resources needed to remediatedeficiencies with products and documentation, leading to optimizing the clients man-hours andreducing costs.•Served as an SME and trusted advisor for audit-related questions to ensure ongoing quality maintainscompliance with ISO9001, ISO 13485, FDA QSRs, and Medical Device regulations.

Education

• Weber State University

  BS, Chemistry / Physics

  1993 — 1998

• East Texas A&M University

  MS, Management

  2005 — 2008

• Liberty University

  Doctor's Degree, Strategic Leadership