Industry Consultant

PROFESSIONAL EXPERIENCE

Industry Consultant:                                 May 2018 – Present

Providing innovating strategic leadership and expertise to implementation of Quality Systems and help to implement efficient compliant system which release value to our customers; Expertise includes:

• Quality system design, development and process transformation

• Update CAPA’s  procedure to comply with regulations. Developed and execute a plan for a backlog in CAPA’s implementation, closing and effectiveness check. Including CAPA review board

• Developed a gap assessment and readiness plan for a successful ISO 13485 and MDSAP upgrades 

• Implementation of relevant SOP’s to comply with FDA 21 CFR 820 and 14971

• Regulatory and Compliance remediation

• Implementation of KPIs

• Global post market regulatory processe

• Medical evaluation of fielded product performance

Air Techniques Inc. Melville, NY.               May 2017 –May 2018

The organization is a global corporation in dental products, with portfolio of utility and digital systems.

Director of Quality Assurance and Regulatory Affairs:  Contacted by the CEO of the Company to assume the responsibility of Management Representative for the facilities and oversee a team of 25 Quality Assurance professionals, in the areas of research and development, manufacturing, customer complaints, documentation control, supplier quality, incoming inspection, and regulatory affairs.

• Performed a Gap analysis to comply with ISO13485:2016 and MDSAP, opened CAPA’s when appropriate.  Follow up and revised CAPA status to readiness plan.  Worked with cross functional team members to ensure the appropriate root cause analysis, corrections and corrective actions were taken.  Developed and implemented CAPA metrics

• Management Representative

• Developed strategic plan to obtain ISO 13485:2016 certification

• Developed strategic plan to obtain MDSAP certification

• Implemented Quality Metrics

• Established a plan to retain and develop high potential employees

• Developed strategy for supplier’s management

• Deployment of new Quality Policy

• Management of Department Budget

• Regulatory Submissions for new and changes to existing products

Stryker Orthopaedics, Mahwah NJ   September 2011 – January 2017

The Company offers a diverse array of medical technologies, including reconstructive, medical, neurotechnology and spine products.

Sr. Director of Quality Assurance- Recon Division: Recruited by the Corporate Sr VP Quality and Regulatory Affairs, to oversee the areas of Quality R&D, Sterilization Sciences, Process Excellence, Product Surveillance, CAPA’s, Internal and External Audits, Documentation/Change Control, three manufacturing facilities and Regulatory Affairs. Eight direct reports; around 120 full time & 35 temporary employees in the department.

• As part of the remediation to a warning letter, worked with all CAPA’s owners to ensure the root cause analysis were appropriate and corrections, corrective actions and effectiveness plan were completed.  Provided guidelines and training on CAPA procedure to SME’s

• Management Representative

•  Developed strategic plan to re organize the department to promote communication and achieve efficiency, ensuring departmental budgets are created and targets are met.  

• Established and achieved KPI’s and long term Goals for the organization.

• Partnered with key stakeholders, Marketing, R&D, Corporate and Operations to establish, document and maintain a QMS which consistently conforms to Stryker, FDA/GMP’s, ISO and other regulatory requirements

• Oversee the Divisional QMS, including policies, procedures and methods in compliance with Corporate, external regulations and industry standards

• Chaired Quality Assurance boards, CAPA’s, NC, Risk Management, Post Market Surveillance. Achieved submissions and approvals for new products and revisions.

• Hosted FDA Inspections for the Division with no major observations; also Notify Bodies assessments to maintain CE Mark certification

• Support Business Development team in the regulatory and quality due diligence for acquisitions and lead the QMS integration of two newly acquired companies

• Responsibility for the Regulatory affairs department during two years

• Review and approved documents and proposed changes that have an impact on quality processes and regulatory compliance, including specifications, material & product disposition, test reports, design changes, validations, product labeling and promotional literature. Approve NC/CAPA and complaint investigations and trending.

• Data bases and complaint investigations for clinical trials

• Built Process Excellence department 12 GB and 2 BB certifications and annual savings of $10 MM

• Selected to attend 2013 Stryker Leadership at Harvard Program

• Nominated Employee of the Year in 2014

Unilife Medical Solutions, Corp. York PA   July 2009 –  September 2011

Medical device manufacturer with business segments: Pre-filled syringes for pharmaceutical companies.

Director of Supply Chain:  Contacted by Sr VP Ops –  to take over the responsibility for the areas; Supply Chain, Strategic Sourcing, Contract Manufacturing, Warehousing and Product Distribution.  Direct P& L responsibility, $80MM budget.   Built the supply chain organization and S&OP process functioning.    Established manufacturing baseline for continuous improvements using lean manufacturing techniques for automated processes, including KPI’s, and suppliers’ metrics, Supervision of five managers.

• Developed strategic plan for the implementation and validation of the ERP system (SAP)

• Realized cost savings of 15% over 2009 budgeted plan - Contract Manufacturing business unit

• Achieved 90% productivity rate vs. 50% previous year & 97% LIFR FY2010

• Managed vendor’s relationship for qualification and negotiation of quality and supplier agreements and raw material inventory levels to support customer fulfillment requirements.

Johnson and Johnson                   May 2000- June 2009

Cordis Corporation,  Warren, NJ   ( 2006 –  2009)

Leading company in interventional medical devices for cardiovascular, endovascular and biliary duct treatments.

World Wide Director External Manufacturing: Due to strong Company requirements to increase the Contract Manufacturing production, was promoted to manage $150 Million Manufacturing Group that produces cardiovascular, endovascular products. Responsible for leading a global organization of 11 internal resources and 12 dotted line Plant Managers  in six U.S. facilities, four in Europe, one in Japan and one in Israel.  Responsible for the turnaround of 2 major Pharmaceutical companies one in Europe and one in US with Quality and Compliance challenges.  Developed and implemented a new Corporate Product Licensing Process reducing “Product Development Time to Market by four months, utilization of Technology transfer methodology resulting in the launch of 4 new products in FY2008 and Q1 2009, increasing annual sales $17MM. 

• Worked with External Partners when SCARs were issued, to open the corresponding CAPA’s in response; supported them in the problem investigation and implementation of Corrective Actions.

• Established required lean manufacturing and Six Sigma training achieving $6.0 MM savings FY2008.  Achieved NO RECALLS FY2007 and FY2008

• Negotiated and implemented a Vendor Management Inventory and Direct Ship process improving inventory turns from 10.5 turns FY2006 to 16.39 FY2008 saving $6.85MM.  Established timelier customer meetings with factories improving Line Item Fill Rate (LIFR) from 80% FY2006 to 98% FY2008. 

• Completed several projects to improve efficiency yielding $2.0 MM in favorable

Cordis Corporation, a J&J Company, Warren, NJ  (2005-2006 )

World Wide Director Supplier Quality Assurance.  As part of the readiness plan for a very critical FDA inspection, was designated world leader of Supplier Quality Assurance to ensure cGMP, U.S. FDA, and country specific regulatory compliance.  Responsible to develop and establish corporate policies and procedures for Suppliers and External Manufacturers, including new product introduction, compliance regulations during development, pre-production QA, Manufacturing QA, Post Marketing QA and Management oversight.  Primary role was to manage a Quality team of 8 people internally located to ensure the compliance of the product to specifications.  Start up a new relationship with key chemicals / drug suppliers for product validations to be used in Cordis coating operations for drug eluting stents.

• Supported CAPA’s investigations and implementation of corrective actions when SCAR’s where non conformities were raised.

• Implemented Statistical Process Control and Skip Lot methods improving first lot pass yield rate from 90% FY2005 to 96% FY2006. 

•  Established monthly Supplier Scorecards and Quarterly Management Reviews reducing scrap $3.5MM, achieving NO PRODUCT RECALLS from any of our External Manufacturers facilities, and managed FDA Inspection in 2006  

• Revised compliance level and plan to move EM’s and Suppliers to acceptable compliance rating, 97% targeted goal achieved.

Cordis de Mexico, a J&J Company, Juarez, MX (2003-2005)

Business Excellence Quality Director. As recognition for the success in the previous role, promoted to this position to develop the five year vision and strategy for the facility and overall Cordis Corporation. Cardiovascular, Endovascular, Neurovascular products  Responsible for building the Business case and ROI for the initiative, persuaded senior management team to approve the initial required investment and  select, train and manage a core team  of 12 project leaders. With an aggressive productivity and plant re-engineering plan, led a plant turnaround that had major productivity inefficiencies, quality problems, and delivery shortfalls, resulting in being recognized as Johnson and Johnson’s Best Plant in America and being awarded with Shingo Prize.  Due to the criticality of the drug eluting stents business assigned one year to manage the Puerto Rican facility, $2.0 B in sales, including mixing, coating and packaging processes.

• Implemented Six Sigma and lean manufacturing techniques achieved $12MM in total savings and a headcount reduction of over 388 line associates and administrators, Implementation of Dashboard metrics.

• Introduced “one piece flow” and level production scheduling resulting in cycle throughput time reduction from 8,739 seconds to 1,355 seconds, an in process inventory reduction of 84%, and increased pieces per hour production from 413 units FY2003 to 720 units Y2005, synchronizing product flow with the elimination of bottle necks.

•  Implemented “localized warehouses” and a component Just In Time pull system on the production floor improving quality yields to 90% in FY2005 from a low of 65% in FY2003 and reducing our one piece product cost from $120/unit to $72/unit.   

• Reduced production space from 92k square feet FY2003 to 64k square feet FY2005, allowing new products in FY2006, and the projection of closing two facilities, benefiting the business with 40% overhead improvement.

•   Reduced our plant Quality defect rate from 1,275 ppm’s in FY2003 to 580 ppm’s in FY2005.

Cordis de Mexico, a J&J Company, Juarez, MX  (2000-2003)

Director of Operations.  Recruited by the VP Operations at a critical point  to start up the Cordis de Mexico facility and drive the project plan, which at the time was delayed, to transfer two major product lines from Cordis U.S. locations. Key role was to manage three Business Units within the facility that produced $750 MM in annual sales, with full P&L responsibility and a headcount of 1,500 union employees and 300 administrators. Design and Manufacturing of   Cardiovascular,  Endovascular & Neurovascular products

• Established and implemented level-schedule production planning resulting in 99% line item fill rate in FY2003 vs. 70% in FY2000

• Implemented the use of Six Sigma resulting in a quality yield improvement in the Diagnostic Catheters Business Unit from 81% to 90% and an annual cost reduction of $6MM.  Introduced Statistical Process Control tools and a Fast Response Team to attack quality issues at their source improving quality defect rates from 1500 ppm’s FY2000 to 1275 ppm’s FY2003. Achieved Zero Product Recalls and a 7 day customer complaint investigation turnaround time in FY2001-FY2003 vs. 45 days in FY2000.  

Cardinal Health                 January 1988 -  May 2000

Cardinal Health Chihuahua,    (1998-2000)

General Manager and Member of Cardinal Health Executive Committee

Cardinal Health, El Paso, TX   (1996-1998)

Custom Products Manager.   Nominated employee of the year.

Cardinal Health, El Paso, TX. (1995-1996)

Technical Supervisor.  

Cardinal Health, Juarez, Chihuahua, MX  (1993-1995)

Human Resources Director, 

Cardinal Health, Juarez, Chihuahua, MX   (1988-1993)

Quality Assurance Superintendent.  

EDUCATION

MBA, INSTITUTO TECNOLOGICO DE CIUDAD, Juarez, Mexico  

BS, Industrial Engineering\Chemistry, INSTITUTO TECNOLOGICO DE CIUDAD, Juarez, Mexico 

Selected to attend 2013 Stryker Leadership at Harvard Program

2014 Tribute to Women & Industry Honoree

Certified Lead Auditor