Acelio L Hernandez

Fortune *** High Growth Medical Devices Transition Organizations

727-***-****

ad1bbh@r.postjobfree.com

Strategic Quality and Regulatory Leader

Senior international business executive with over 25 years of success leading global quality and regulatory organizations. Create sustainable business processes and quality systems that are compliant to all relevant industry standards. Demonstrated track record of implementing business processes that improve profit and customer satisfaction in global mass production environments and complex design and development projects. Experienced in organization change management and leading large scale continuous improvement projects that support businesses’ financial success.

PROFESSIONAL EXPERIENCE

Sientra Inc Franklin, WI

Director of Quality Operations 2022-2023

Responsible for Quality Operations

Manage Quality Engineering Department at Franklin, Wisconsin facility

Support R&D in the development and transition of new product to Manufacturing

Developed strategic customer Quality growth plan

Drove and led continuous improvement projects as they related to customer satisfaction, on-time delivery, and RMA transaction process that resulted in improved NPS scores and new business awards

Led the establishment and implementation of a behavior-based quality system, leading to 15% improvement in yields

Manage Post Market Surveillance Department

KMC Systems, a Elbit Systems of America Company Merrimack, NH

Executive Director of Quality and Regulatory Affairs 2020-2022

Responsible for Global Quality and Regulatory compliance

Responsible for the development and implementation of the strategic quality plan for the medical division

Implemented validated Part 11 Manufacturing Execution System

Developed strategic Medical customer Quality growth plan

Drove and led continuous improvement projects as they related to customer satisfaction, on-time delivery, and RMA transaction process that resulted in improved NPS scores and new business awards

Led the establishment and implementation of a behavior-based quality system, leading to 15% improvement in yields

NuVasive Corporation Dayton, OH

Quality Engineering Manager 2019-2020

Manage Quality Engineering Department at Dayton, Ohio facility

Support R&D in the development and transition of new product to Manufacturing

Assure the development and implementation of Quality Systems for the plant to ensure the delivery of quality products to the customer

Provide strategic guidelines to maintain the fulfillment of the Regulatory Quality System such as 21 CFR 820, ISO 13485 and ISO 14971 requirements supporting current business goals and ISO 14971 requirements

Inventus Power Woodridge, IL (remote role)

Sr Director Global Quality and Regulatory Affairs 2018-2019

Inventus Power is the global leader in advanced battery systems. We specialize in the design and manufacture of Li-ion battery packs, smart chargers and efficient power supplies across a broad range of portable, motive and stationary applications.

SKILLS

Business Development Support

New Product Development & Launch

QA & QC

Supply Chain Management

Operations

Change Management

P & L Impact

Mergers and Acquisitions

Coaching & Mentoring

HIGHLIGHTS

Manages global relationships and dynamic results-driven teams.

Delivers inventive business strategies that improve operational cost and efficiency.

Streamlines complex global operational problems into revenue opportunities.

EDUCATION

Bachelor of Science,

Computer Engineering

Technology

Tampa Technical Institute

LANGUAGES

Read, write, and speak Spanish and English fluently

Harmonized the operational aspects of $200M acquired manufacturing facilities by merging into one quality management system that is ISO 13485-2016 and FDA QSR compliant

Drove and led continuous improvement projects as they related to customer satisfaction, on-time delivery, and RMA transaction process that resulted in improved NPS scores and new business awards

Installed FDA readiness procedure and training in global medical sites and successfully guided the business through its 1st FDA compliance inspection

Led the establishment of a new medical site in Mexico installing QMS processes which supported the development and training of 300 workers

Led the roll-out and implementation of a behavior-based quality system, “Patient Priority Wall,” into all medical sites, leading to 10% improvement in yields

Provided executive leadership team input for strategy road-map by creating technology risk overview with regards to implantable products

Supported global talent management program by mentoring and coaching staff members

Nypro, a Jabil Company Clinton, MA

Global Director Quality, Healthcare 2011-2018

Nypro is a global leader in plastics contract manufacturing. A vertically integrated, global solutions provider of manufactured precision plastic products, tooling and automation.

Led the global healthcare Quality organization comprised of 1,500 personnel for a business unit in five locations including responsibilities for operations, R&D, supply chain and business development support for quality

Led Jabil through first FDA investigation on a PMA class III device

Led the organization through globalization of quality management system to support footprint expansion in Singapore and New York

Provided Quality and Regulatory oversight for a complex emerging market R&D project with a budget of $50M that covered software, human factors, mechanical, electrical, and fluidics design and development

Drove quality metrics that improved yields to cumulative average of 99% across business units and reduced product lead times by 15% by leveraging Lean and Six Sigma methodologies

Represented the Quality voice through Jabil’s M&A activity on three large healthcare acquisitions

Led Supplier Quality Globally for Healthcare

Innovative Medical Device Solutions (IMDS) Logan, Utah

Director of Quality Assurance and Regulatory Affairs 2010-2011

IMDS is a leading innovator in contract, full-service medical device development and manufacturing, providing innovative solutions from product concept to real life, especially within the orthopedic industry

Managed Quality Supervisors/Managers at the Logan Utah facility

Managed all aspects of Quality Department which consist of Receiving, Documentation, Internal Audits, Supplier Quality, CAPA & Complaints, Design Quality transfer support and Manufacturing Quality both at Engineering and Inspector levels as well as all Engineering Change Orders

Plant FDA/Quality representative for the Logan Manufacturing facility

Supported R&D in the development and transition of new product to Manufacturing

Assured the development and implementation of Quality Systems for the plant to ensure the delivery of quality products to the customer

Provided strategic guidelines to maintain the fulfillment of the Regulatory Quality System such as 21 CFR 820, ISO 13485 and ISO 14971 requirements supporting current business goals

Covidien (now Medtronic) Tijuana, Mexico

Senior Quality Assurance Staff Manager 2007-2010

Covidien is a global leading supplier of medical devices, pharmaceuticals and medical supplies and has pioneered a number of medical advances including contrast media, pulse oximetry, electro surgery, surgical stapling and laparoscopic instrumentation. The Tijuana site is one of its largest and more complex operations with approximately 3,200 employees serving four different business units.

Managed Quality Supervisors/Managers at the Tijuana facility in support of three Global Business Units, both domestic and international, for entire Quality Department comprised of 600 personnel covering the entire QMS(Ex. Engineering,Inspection, Complaints, Document Control and CAPA)

Dual Reporting responsibility into VP of WW Operations and VP of WW Quality, provided executive level reports and strategy documents on continuous improvement plans with regards to Quality and regulatory compliance

Supported numerous new products launches out of R&D with regards to manufacturing approval and documentation submission for product 510k’s submissions to the FDA

Oversaw and led the Failure Analysis lab. Drove and lead the operations in robust corrective actions to support closure of issues as reported. Provided data as needed on FA corrective actions to the FDA as needed to support closure of MDR reporting.

Mentored and Developed team members on “Quality Begins With Me,” behavior-based quality system

Led improvements in operational metrics with regards to Yield, Cost of Quality, RMA turn-around time, and scrap which all led to annualized savings of more than $1 million USA and improved voice of customer quality

ConMed Corporation Largo, FL

Quality Project Manager 2005-2007

A Global Medical Device Company

Supported and provided input to R&D on product transfers into mass production, and ensured good manufacturing processes and principles were followed utilizing advance quality planning

Led Quality department including engineering, technicians, and inspectors

Developed and launched new and improved standard operating processes and procedures that improved PFMEA, DFMEA, Prototype, and Production Part Approval Process that helped improve time to market of new product launches by 25%

Baxter Healthcare Corporation Largo, FL

Principal Quality Engineer 1995-2005

A Global Medical Device Company

Managed and oversaw the full Quality Plans for a Hemodialysis Medical device, including MFG Quality Plan, Supplier Management Plans, Design Verification Quality Plan and ultimate submission package to the FDA

Implemented APQP for manufacturing facilities and suppliers

Supervised a team of four engineers including process quality, supplier quality, and reliability

Supervised failure analysis laboratory, which handled returned goods and complaints

Unisys Corporation Oldsmar, FL

Quality Assurance Engineer 1985-1995

A worldwide information technology service and manufacturing company that is heavily involved in government computer systems and security testing.

Provided quality floor support for the FAA and U.S. Navy projects

Tasked with gathering, evaluate and report manufacturing quality data for Test Engineering and R&D groups

Provided support for the refurbishment depot

Maintained product design integrity for FAA and U.S. Navy projects

Tested and troubleshoot printed circuit boards and power supplies for FAA and U.S. Navy projects

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