Ruben Sanchez

Ruben Sanchez Email and Phone Number

Global Quality Management | Team Builder | FDA Warning Letters | Continuous Improvement | Product Development | Global Medical Device Regulation | Reduce complaints and field actions | Mutimillion-Dollar Cost Reduction @ Abbott
Ruben Sanchez's Location
Irvine, California, United States, United States
Ruben Sanchez's Contact Details
About Ruben Sanchez

I am a versatile Quality Assurance Leader with expertise championing diverse teams in delivering best-in-class solutions to exceed business goals. I build high performing teams and solve complex regulatory challenges, including warning letters, product detentions and 483s.I strive to implement a robust quality system and promote a cultural change to guarantee quality compliance. I have found that a day to day quality system adherence guarantees smooth quality system audits, providing solid results so the business can continue to grow.I enjoy continually optimizing manufacturing processes and quality testing to make the supply chain more efficient and contribute to business bottom line. In addition to ensuring compliance, every year my quality strategy includes optimization projects aligned with business needs.I have developed a Cost of Quality Model to translate quality efforts are to dollars and cents, connecting the quality strategy to business imperatives. This facilitates continuous manufacturing and quality processes improvement in areas that provide the most significant impact to the operation.I create a collaborative relationship with my operational business partners to facilitate timely, quality products in the distribution center. I have a deep understanding of quality processes, products use, manufacturing and product design that allows me to swiftly make the right call.I am a true innovation driver, working with R&D to ensure product launches are attained on time. My deep understanding of global medical device regulations, design control process and risk management allows me to facilitate the development of high-quality products, compliant to regulations and launched according to business expectations.MY KEY STRENGTHS:Leadership | Team Builder | Quality Assurance | FDA Warning Letters | Continuous Improvement | Product Development | Global Medical Device Regulation | Failure Investigation | CAPA | Cost of Quality | Warning Letters | 483s | Cost of Quality Model | Regulatory Affairs | Strategic Planner | Results Driven | Process Validation | Quality Audit | M&A | Product Transfers | Innovation | R&DContact me at rubensanchezqa@gmail.com

Ruben Sanchez's Current Company Details
Abbott

Abbott

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Global Quality Management | Team Builder | FDA Warning Letters | Continuous Improvement | Product Development | Global Medical Device Regulation | Reduce complaints and field actions | Mutimillion-Dollar Cost Reduction
Ruben Sanchez Work Experience Details
  • Abbott
    Director Of Operations Quality
    Abbott Nov 2022 - Present
    Abbott Park, Illinois, Us
    I oversee product quality for the CRM division US sites. I create optimal balance between compliance and efficiency to ensure a high quality product is provided to customers at all times. Products are US class III implantable pacemakers, defibrillators and cardiac monitors, including delivery catheters and electronic manufacturing.
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  • Abbott
    Director Global Quality Systems And Compliance
    Abbott Sep 2020 - Oct 2022
    Abbott Park, Illinois, Us
    I was recruited to Abbott Cardiac Rhythm Management division (CRM) to lead quality systems and compliance efforts for the division that includes 6 domestic and international sites with over $2 billion sales. The products are FDA Class III pacemakers, defibrillators and heart monitors. I was responsible for EUMDR transition project ensuring timely approval to continue to sell products in Europe. I was also responsible for the healthy operation of the quality systems including CAPA, Audits, Doc Control, Sterilization, Training, Management Review, etc.
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  • Avanos Medical
    Global Director Qa Avanos (Formerly Halyard Health And Kimberly-Clark Corp.)
    Avanos Medical 2015 - 2020
    Alpharetta, Georgia, Us
    I was promoted to lead team of 300+ professionals across 3 business with $700MM in sales at 5 manufacturing sites and 2 design. I facilitated seamless partnerships across locations including France site; earned and maintained MDSAP certifications. Infusion pumps, nerve ablation, respiratory tubes, enteral feeding, IVD device and drug. Increased efficiency saving $2MM by providing strategic oversight and leading execution of quality strategies, including implementation of Cost of Quality (CoQ) programs to contribute to business goals. Liaised between company and regulatory agencies to deliver zero FDA 483 observations, zero major notified body NC and multiple 510(k) clearance and M&A integrations to support company growth. Fostered cooperation between stakeholders reducing product complaints year-over-year up to 10% contributing to customer satisfaction.
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  • Avanos Medical
    Director Qara (Kimberly-Clark Corp.)
    Avanos Medical 2012 - 2015
    Alpharetta, Georgia, Us
    I was recruited to Kimberly-Clark to lead quality and regulatory functions for $170MM infusion pump business with 1 design center and 2 manufacturing facilities. Job included design quality assurance, quality operations, regulatory affairs, complaints management and quality systems. Resolved Warning Letter by implementing Quality Compliance Plan and earning zero 483 inspection to be able to focus on business growth and new product development. Assembled high performing team to implement enhanced quality systems including design control, complaint management, corrections and removals to ensure regulatory compliance and product quality. Optimized QA process saving $4MM via sampling optimization, relocating testing facilities and implementing Statistical Process Control (SPC) to optimize the manufacturing process.
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  • Medtronic
    Senior Director Quality Assurance
    Medtronic 2010 - 2012
    Minneapolis, Mn, Us
    I Led quality assurance at facilities across U.S., Latin America, South America and Europe with over $4.3B in revenue. FDA class I, II and III devices including endomechanical surgery, sutures and needles, biological and synthetic mesh implants, spine sealant, etc. Improved quality of endomechanical surgical product lines by optimizing process transfer from U.S. and Puerto Rico to Dominican Republic to manufacture more cost-effective product.
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  • Medtronic
    Director Of Quality Assurance
    Medtronic 2006 - 2010
    Minneapolis, Mn, Us
    I oversaw quality assurance teams at five sites in Mexico (3), Ireland and Italy for a $ 2B revenue division. Endotracheal and tracheal tubes, respiratory circuits, oxygen sensors, enteral feeding, convenience kits, sterilization, etc.  Led resolution to multiple regulatory challenges, including FDA Warning Letter, zero 483 inspections and import detentions expanding business growth. Implemented cultural change with initiatives focused on preventative systems including Quality Week, Cost of Quality Program, Advanced Quality Planning and SPC to ensure product quality.
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  • Medtronic
    Quality Assurance Manager
    Medtronic 2001 - 2006
    Minneapolis, Mn, Us
    I was the quality leader (management rep) of a manufacturing facility surgical sutures biological and synthetic.  Championed Advanced Product Quality Planning program and sampling optimization to reduce unnecessary testing and reduce scrap $600K. Assembled a high performing team that produced great audit results, process improvements earned and corporate awards facilitating expansion of the site.  Exported high caliber talent to other corporate locations.
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  • Baxter
    Qa Planning Section Mgr
    Baxter 1996 - 2001
    Deerfield, Illinois, Us
    I Developed and executed projects to increase capacity, reduce variation and cost of manufacturing processes. Promoted from Process Engineer to Engineer Superintendent to Section Manager. Assembled high performing team and led implementation of Advanced Product Quality Planning and (APQP) and Statistical Process Control (SPC) to improve quality and reduce scrap. Led product transfers from Puerto Rico to Dominican Republic to reduce cost and improve quality. Developed and executed multiple process and software validations to support manufacturing.
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Ruben Sanchez Skills

Cross Functional Team Leadership Iso 13485 Fda Design Control Gmp Corrective And Preventive Action Continuous Improvement Fmea 21 Cfr Part 11 Change Control Dmaic Design Of Experiments Iso Quality System Good Manufacturing Practice Quality Assurance U.s. Food And Drug Administration Quality Management Product Quality Medical Devices Regulatory Affairs

Ruben Sanchez Education Details

  • Instituto Tecnológico De Santo Domingo
    Instituto Tecnológico De Santo Domingo
    Business
  • Universidad Autónoma De Santo Domingo
    Universidad Autónoma De Santo Domingo
    Quality
  • Instituto Tecnológico De Santo Domingo
    Instituto Tecnológico De Santo Domingo
    Engineering

Frequently Asked Questions about Ruben Sanchez

What company does Ruben Sanchez work for?

Ruben Sanchez works for Abbott

What is Ruben Sanchez's role at the current company?

Ruben Sanchez's current role is Global Quality Management | Team Builder | FDA Warning Letters | Continuous Improvement | Product Development | Global Medical Device Regulation | Reduce complaints and field actions | Mutimillion-Dollar Cost Reduction.

What is Ruben Sanchez's email address?

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What is Ruben Sanchez's direct phone number?

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What schools did Ruben Sanchez attend?

Ruben Sanchez attended Instituto Tecnológico De Santo Domingo, Universidad Autónoma De Santo Domingo, Instituto Tecnológico De Santo Domingo.

What are some of Ruben Sanchez's interests?

Ruben Sanchez has interest in Motorcycling, Christianity, Cruises, Traveling, Sweepstakes, Electronics, International Traavel, Reading, Sports, Automobiles.

What skills is Ruben Sanchez known for?

Ruben Sanchez has skills like Cross Functional Team Leadership, Iso 13485, Fda, Design Control, Gmp, Corrective And Preventive Action, Continuous Improvement, Fmea, 21 Cfr Part 11, Change Control, Dmaic, Design Of Experiments.

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