Hugo A. Felix

100 New Village Greene Drive · Honey Brook, PA 19344

(646)279-2609 · hfelix@alum.mit.edu

 

 

director-level leadership

Quality Systems ~ Design Control ~ Operations Quality ~ Quality Engineering

Dedicated quality engineering professional with a wealth of expertise enhancing the performance and profitability of diverse organizations within the Medical Devices, Pharmaceuticals and Pharma Combination Devices industries.  Dynamic leader with proven ability to guide cross-functional teams through entire project life cycle from concept to production.  Demonstrated track record of success in development, redesign and execution of Design Control, Process Validation, Operations Quality and Quality Systems to drive business results and create a competitive advantage.  Superior technical expertise combined with solid business acumen; leverage exceptional communication skills and understanding of regulatory environment in creation of innovative compliance solutions.  

 

Areas of expertise include:

 

PROFESSIONAL EXPERIENCE

 

Director, Design Quality Assurance – Siemens Bard Access SYstems (2015 – Present)

Dircetor in charge of Bard Access Systems New Product Development Quality Engineering team.  Head of functional team of 6 Managers, 19 Quality Engineers, 3 Technicians and 3 Technical writers.   In charge of strategy, budget, performance and organizational development.  Design Control representative for the Bard Access Systems division. 

 

Selected Achievements:

·               Oversee development of 600MM division of both disposable catheters, implantable ports and ultrasound equipment.

·               Reorganized and reenergized functional team improving team engagement and productivity.

·               Brought team to full staffing for first time in 3 years by closing 6 open heads through internal and external hires.

Director, Design Quality Engineering – Siemens Healthcare Diagnostics CAI Business Unit (2014 – 2015)

Dircetor in charge of CAI Business Unit Instrument development cross-site Design Quality Engineering team.  In charge of strategy, budget, performance and organizational development of a team of 3 design quality engineering associates and a contract associate supporting Software and Instrument product development.  Design Control representative for the CAI business unit in the Siemens Healthcare Design Control Governance team.  Design Quality Representative in both the Analyzer Change Review Board and Product Lifecycle Management Governance Board. 

 

Selected Achievements:

·               Technical lead for the successful redesign of Siemens Healthcare Diagnostics worldwide design control system

·               Served as CAI BU Design Quality Product Lifecycle implementationand Risk Management review lead

·               CAI BU representative in Siemens Corporate Healthcare Quality workshops

 

Johnson & johnson family of companies · 2002 – 2014

Multi-national manufacturer of pharmaceutical, diagnostic, therapeutic, surgical and biotechnology products.

 

WW Risk Management Director Global Orthopaedics – Depuy Synthes (2013 – 2014)

Risk Management System owner for the DePuy Synthes companies.  Heading worldwide design and deployment of an Company Group wide product risk management system across all DePuy Synthes design and manufacturing locations worldwide.  Leader of global remediation workstream for Quality Planning and Risk Management.

 

Selected Achievements:

·               Headed implementation of improvements to meet EN ISO 14971:2012 deviations,

·               Improved use of risk management tools throughout the product lifecyle

·               Established effective metrics for monitoring the risk management system.

·               Headede remediation of risk management files for DePuy Synthes to comply with EN ISO 14971:2012

Quality Director PD QE – Acclarent, Inc (2012 – 2013)

Director of Quality Engineering focused on the development of ENT medical devices.  Direct all aspects of Quality function in the Rhinology business unit and main Quality representative for business unit in 3^rd party audits.  Responsible for the budgeting, strategic direction and member of the Rhinology business unit leadership team.  Post Market Surveillance system business unit lead.  Quality Director of a Business Unit Product Development QE team of 5 engineers.

 

Selected Achievements:

·               Wrote portions of FDA warning letter response related to design control issues.

·               Reorganized team to improve product development and system support needs.

·               Implemented tailored development plans to accelerate associate growth and improve team capabilities

·               Improved development system flexibility to accelerate product development cycles.

 

Sr. Manager NPD QE – Codman Neurovascular (2011 – 2012)

New Product Development QA Sr. Manager for development, manufacturing and integration of Neurovascular Products.  Neurovascular Business Unit Quality Assurance Franchise Lead.  Orchestrate all aspects of Quality function in restart of domestic manufacturing site and oversight over remote operation sites.  Managed complaint closure of design related complaints and new suppliers for development projects until post launch product stability was achieved.  Orchestrate new product regulatory submissions, providing comprehensive product quality data and closing gaps for MDD updates of marketed products.  Senior Manager of a NPD QE team of 5 engineers and 1 technician with dotted line oversight of Mexico operations with 1 Manager, 3 engineers and 6 technicians.  Handled a 1.5 MM budget for both development and operations quality.

 

Selected Achievements:

·               Received GLP Award for effective integration of Micrus Endovascular Products to Codman Quality System, overcoming organizational challenges in blending different corporate cultures.

·               Lead quality remediation teams overseeing gap identification and remediation of Risk Management, Process Validation, Preventive Maintenance and Calibration systems at acquired sites.

·               Managed NPD QE team transition to Franchise model and integrated all 4 Codman sites into a single organization.

·               Deployed CAPA, NCR and Internal Audit Systems to all CNV remote sites (4 sites)

 

Principal Engineer NPD QE – Codman/Cordis Neurovascular (2008 – 2011)

Leverage quality expertise and project management skills as New Product Development QA Team Lead for development, manufacturing and integration of Neurovascular Products.  Orchestrate all aspects of Quality function in restart of domestic manufacturing site and oversight over remote operation sites in Florida and Juarez, Mexico.  Orchestrate new product regulatory submissions, providing comprehensive product quality data and closing gaps for MDD updates of marketed products.  Direct reporting responsibility for NPD QE team of 4 engineers and 1 technician in addition to remote operations with 1 Manager, 4 engineers and 6 technicians for a total organization of 30 associates. 

 

Selected Achievements:

·               Lead host for Notified Body 3^rd party audits of Miami Lakes site and Co Lead for FDA audits for CNV Business Unit at Raynham site.

·               Spearheaded integration of Cordis Neurovascular Products to Codman Quality System, overcoming organizational challenges in blending different corporate cultures.

·               Lead quality remediation teams overseeing gap identification and remediation of Design Controls, Risk Management, Process Validation and Calibration systems at acquired sites.

 

Data Quality Manager/Site Supplier Quality Lead – Cordis LLC (2005 – 2007)

Provided leadership to team of 8 professionals based in San German, Puerto Rico in delivery of Product Quality Data to the Cordis Franchise worldwide, ensuring timely and thorough analysis in support of quality investigations, routine trending, management review metrics and annual product reviews.  Site Supplier quality representative managing nonconformances and supplier quality relationships and reporting.

 

Selected Achievements:

·               Improved process efficiencies, reducing data entry lead time by 50% through cross-functional coordination. 

·               Slashed payroll expenses by 70% while maintaining superior customer service.

·               Led Franchise Wide Annual Product Review activities for Drug Eluting Stent platform.      

NPD Staff Quality Engineer – Cordis LLC (2004 – 2005)

Directed Design Control (DC) activities for Coating process development pilot manufacturing module.  Formulated DC and Quality System requirements for First in Man release. 

 

Selected Achievements:

·               Drove improvements in development coating module process, reducing deviations by 84% in first 4 months.   

·               Enhanced design control system, incorporating key pharmaceutical requirements to device development.       

 

NPD Senior Quality Engineer with CardioVations, an Ethicon Franchise (2002 – 2004)

Managed execution of Design Control activities for novel Automated Anastomoses Device (AAD).  Championed Design Validation and Verification Studies.   

 

Other previous roles within Johnson & Johnson Family of Companies: 

Operations Quality Assurance Engineer with Ethicon (1991-1996) and NPD Quality Engineer with Cordis (1996-1998).

 

 

roche pharmaceuticals · 2000 – 2002

Global leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. 

 

Senior Quality Systems Engineer

Leveraged regulatory and compliance experience as member of newly formed Quality Engineering group at Roche, tasked with re-engineering quality systems to address Warning Letter Issues.  Enhanced effectiveness of systems and processes; revitalized the Annual Product Review System and automated the Stability Data Trending System for marketed products. 

 

C.r. bard · 1999 – 2000

Leading multi-national developer, manufacturer and marketer of life-enhancing medical technologies. 

 

Manager, Regulatory Sciences Systems Support

Served as lead QSIT Auditor of manufacturing facilities, OEM, Component and Services Suppliers, product websites and sales offices.  Initiated Corporate Best Practices for Labeling, SPC and Process Validation. 

 

cormedica · 1998 –1999

Designer, developer and manufacturer of PTER products.

 

Manager, Quality Assurance

Launched complete quality system for an Active Medical Device in compliance with ISO9000 and FDA QSR in 10 months.  Completed Risk Assessment of a transluminal endocardial revascularization device and embedded software.  Audited, Qualified and managed OEM, components and design services suppliers in support of virtual manufacturing activities.  

 

 

 

 

 

 

EDUCATION & CERTIFICATIONS

 

Bachelor of Science in Mechanical Engineering Massachusetts Institute of Technology, Cambridge, Massachusetts	ASQ Certified Biomedical Auditor   Former CQE, CQA and CRE
Executive Certificate in Negotiation Notre Dame Mendoza Business School, South Bend, Indiana	J&J First Line Leadership I & II Training Graduate
Graduate Certificates in Management and Marketing Tulane Freeman Business School, New Orleans, Louisiana	Johnson & Johnson Black Belt Certification Candidate

AWARDS & MEMBERSHIPS

ASQ Senior Member	Global Leadership Profile Award Recipient 2012
United Way Campaign Canvassing Volunteer	HOLA Raynham Chapter Co-Chair