Engineer Management

BRENDA MARIS

281-***-****(H); 346-***-****(C)

*************@*****.***

SUMMARY EXPERIENCE

Systems Program Developer, Customer Centric Systems, Training/KPIs: 20 yrs

Compliance (FDA- cGMPs/QSRs; CAPA; Validation; ISO 9000/13485; HSEQ Audits): 15 yrs

Vendor-SCM; Scorecards; Quality Trainer; Knowledge Management: 10 yrs

Project/Risk Management/Change Control (FMEAs/ISO14971): 15 yrs

New Product Introduction: 9 yrs

Production & Quality Engineering: 20 yrs

Ops Excellence (Value Chain Capabilities; LSS/Auditing; Maintenance): 15 yrs

Team Development (HPTs; Employee Growth/Succession Planning; Skills Training): 15 yrs

Education: BS/MS Chemical Engineering – Polytechnic of New York

Active Certifications: ASQ CSSBB; ASQ CQE; ASQ CQA; PMI PMP.

Retired Certifications: CHMM; COSS; RSO

Bilingual (English/Spanish)

AIR LIQUIDE USA 2011-2016

Mgr cGMP & Ops Excellence; 6 Reports

OPERATIONAL EXCELLENCE

Led Manufacturing High Performing Team (HPT) Model Initiative in US

Established Organizational Infrastructure For LSS/Continual Improvement

Program Management of Lean Six Sigma Projects - $6MM Savings/Efficiencies

Established Statistically Based Specification/Inspection Program

Performed Mfgr/Transactional Capability Studies-Supporting LSS Project Pipeline

Led Implementation of Integrated Management System (HSEQ) Audit - $800k Savings

Established Ops Excellence Cascading Balanced Scorecards by Zone

Implemented “One Air Liquide” Voice of the Customer (VOC) across for 4 divisions

Guided Plant Managers on Ops Excellence Implementation/Prioritizing Project

Established Best Practices/Knowledge Sharing Google Communities

COMPLIANCE & RISK MANAGEMENT

Maintained cGMP Audit Program-60 Med/Food, ISO 9000 Certified Sites

Led Certification Efforts for 50 Sites; Trained 10 Auditors

Reduced Noncompliance (COPQ) by 1.6MM/yr

External Audit Representative (State, Local, CBs, Customer, FDA)

Authored/Delivered FDA Training Modules; Corp/Site Docs; Annual Product Reviews

Performed Equipment/Process Validations & Change Control

Managed Field Noncompliances/Customer Complaints; CAPA Program; Recalls

Leads/Performs Gap Analyses (PFMEAs, DFMEAs, HACCPs)

Consultant - Avenbi Associates (Quality/Productivity/ISO) 2010-2015

cGMP & CQA Audit Exam Trainer for Merck Animal Health

QE/Lean Six Sigma/Auditing Trainer for ASQ Baton Rouge Section 1521

ISO 9001 Auditor Trainer For Economic Development Branch of Lafayette, LA

MALLINCKRODT (Formerly IKARIA) Drugs/Devices

Mgr, Engineering Projects; 2 Reports; Led Xfunctional Teams

ENGINEERING

Led INOcal Devices Product Design - Manufacturing Unit DBI – Commissioning- Stability Program – Validation - Commercial Launch (Savings =$3MM/yr )

Developed Business Cases

Served as Process Engineer/Optimized Mfgr & Lab Capabilities/Inspection Plans

Project(s) Budgeting/Capital Appropriation Requests Management

Led Cross Functional Technical Personnel on Kaizen Projects (Savings = $1MM/yr)

Authors Compliance/Mfgr SOPs/Technical Reports/Annual Product Reviews

2005-2010

Quality Systems Supervisor; 6 Reports

Trained QS/Mfgr team in QE/LSS Techniques: RCA, Sampling Plans (Discrete/Variable), Gage R&R, SPQC/Process Capability, FMEA, Vendor Evaluation, Kaizens/DMAIC/DFSS, & Control Plans

Implemented Performance Monitoring Scorecard KPIs (Mfgr/Quality/Service)

Reduced Open Noncompliances by 75% in 1st year

Redesigned Internal/Vendor Audit Program As Risk Based Improving QS Resource Usage, CAPA Effectiveness, & Reducing Repeat QIRs by 30%

Led xfunctional Team in Reducing #1 Complaint Type by 70%

Streamlined Complaint & Doc Control Processes by 25%

Site Quality Engineer/Process Engineering Support

Conducted product trend analyses for annual review submissions to FDA

Developed of QA Inspections Reduced Sampling Justifications (Savings = $300k/yr)

Developed of Site Manufacturing Key Performance Indicators (KPIs) Scorecard

Quality Rep For NPI Teams/Established Specs & Inspection Plans

Authored CMC FDA Submission for Bulk CO

Directed/Interpreted R&D Experiments Ultimately Serving as Basis of Final Unit Design

Determined Engineering Specs for Bulk process equipment

GE PLASTICS, (Production Engineer) 2000-2004

Increased capacity by 20%; adding $1.1MM/yr in liquidations.

Partnered with supplier to reduce heater cleaning costs; Savings=$75k/yr.

Developed Online Heater Flushing Process, Savings = $50k/yr.

Digitized Equipment/EHS Inspections; Savings=$20k/yr

Digitized Lab Data Transfer; Savings = $50k/yr

Identified cooling tower chemical substitute, Savings = $55k/yr

DFSS for Digitization of Production/Financial Reports; Workout=12 Manhours/day

Supply Chain Leader

DFSS for Relocating Warehouse; Transportation Savings= $275k/yr.

Optimized Scheduling & Delivery To Improve OTD by 30%

Formalized Logistics program (policies, SOPs, WIs) to standardize execution

Established Railcar Supply/Demand Metrics for Improved Management; Savings=$75k/yr

Reduced Railcar Repair Times; Savings= $20k/yr

Drove Quality System Implementation; Trainer of QS9000 Auditors.

Management Award for QS9000 Leadership: 12/01

JOHNSON & JOHNSON (Sr Quality Eng – IVD Productline) 1995-1998

Determined new/existing product internal manufacturing specs to reduce noncompliances

Established statistical sampling plans for FDA compliance

Authored/Executed process/component/equipment validations

Reduced open noncompliances by 70% and reduced closure time by 90dys

Improved supplier capabilities for components by 1-2 sigma units

Reduced lab testing by 60% by statistical equivalence studies of instruments

Audited interdepartmental processes for FDA compliance streamlining systems by 30%

Monitored effectiveness of test method, raw material, component and packaging/shipping validations through regular analysis of noncompliances, customer complaints, & process performance

EXXON PLASTICS PLANT (Env Supvr - ISO 9000 Site Rep; 2 Reports) 1989-1995

Insured plant compliance with state and federal environmental regulations in the areas of water, waste, radiation, and air. Internal/external Environmental compliance representative.

Trained 100 employees in Six Sigma, ISO 9000, & Facilitated Improvement Projects

SOCIAL/COMMUNITY RESPONSIBILITY

Active Officer of Baton Rouge ASQ Chapter

Lead Assessor Under Malcolm Baldrige National Quality Award for LQF

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