Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Antonio Rivera Negrón

Urb. Monte Alto, Gurabo

Summary

Effective professional with 12 years of experience focused and diligent with commitment to fostering corporate mission. Hardworking and passionate job seeker with strong organizational skills eager to obtain an Engineering, or related field position. Able to bring proven success in driving new product transfer projects, continuous improvement, cost reduction and business continuity initiatives in Quality Engineer roles. Ready to apply my knowledge and skills in a highly technical and competitive environment to achieve company success.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Advance Quality Engineer (AQE) Lead

BD Humacao
02.2021 - 09.2023
  • Responsible of the AQE Engineering team implementation overview of new product transfer projects, supplier improvements and remediation initiatives, and cost improvements projects (CIP)
  • Resourcing allocation and workload distribution of key plant projects based on company priorities
  • High level decision making and strategic projects planning for execution/implementation
  • Provide guidance and direct mentorship to team members to develop knowledge on transfer deliverable, projects implementation phases and active project team collaboration
  • Delegated QA Manager position at BD Delran, NJ from Dec – Jun 2021.
  • Monitor plant QA daily priorities and metrics (Incoming and In-process Inspectors scheduling, Non-Conformance, CAPA, SCARs, Audits, Calibrations, Preventive Maintenance, Training)
  • Conduct Management Review
  • Provide project tracking tools and statistical training for internal QA associates development

Advance Quality Engineer (AQE) / Sr. AQE

BD Humacao
08.2015 - 02.2021
  • Assure compliance with Quality System Regulations for design transfer projects, process improvements, cost improvements and business continuity initiatives
  • Support New Product Development Transfer Phases deliverables (Conceptual Design, Process Development, Process Qualifications/Validations, Product Processes Implementation and Post Launch Surveillance Review)
  • Develop new product cost analysis, tooling design specifications and certifications, support AME on tooling and equipment purchase orders (POs), manufacturing line/equipment layout, process flow efficiency (3Ps methodology) and Technical Project Risk Assessments to assure risk mitigation and project suitability
  • IQ, OQ, Cleaning, CSV, TMV, and PQ protocols and reports (PPQ product performance).
  • Data analysis through statistical techniques (DOE, Regression, Anova, etc) for Specification Derivations and Process Characterizations
  • Develop Statistical Process Control Techniques (SPC, i.e. Control Charts)
  • Product launch DMR (Specifications, SOPs, BOM, Inspection Procedures (IP), Manufacturing Procedures (MP), and Manufacturing Traveler, PFMEA, PRS, PPS)
  • Responsible for specifications/inspection creation and component qualifications (CQ). Assess First Article Inspection, Process Control Plans, Process Capability, Gage R&R, Stability Testing and Certificates of Compliance/Analysis.
  • Responsible for supplier development activities, conduct Material Review Report (MRR), CAPA and Supplier Corrective Action Request (SCAR) investigations
  • Engineering Production Orders, Design Verification Studies, Critical and Clinical Builds, Technical Document Reports
  • Conduct internal quality audits to assure procedures compliance
  • Experienced with combination product regulations and quality requirements (animal origin medical device and pharmaceutical drug combined product).
  • Six (6) product launches from design platform to post launch phase.

Quality Engineer and QC Supervisor

BD Humacao (CR Bard PR)
12.2013 - 08.2015
  • Material Review Reports (MRR) and CAPA owner to investigate non-conformance events in order to identify root causes and generate corrections, corrective and preventive actions
  • Assess Environmental Incidents investigations with QA Laboratory
  • Conduct Data Trending meetings and execute kaizen initiatives to reduce the scrap (units’ rejections)
  • Data analysis and cost reduction projects using DMAIC methodology for improvements implementation
  • Conduct Process Improvement Changes, Risk Assessments, IQ, OQ, and PQ protocols and reports
  • Supervising Quality Inspectors of manufacturing line distributing daily priorities and workload per production schedule
  • Certify Quality Inspectors according to manufacturing line Inspections Procedures (IPs)
  • Assigned to process improvements projects and product development activities
  • Experienced with combination product regulations and quality requirements.

Supplier Quality Engineer

CR Bard Puerto Rico
08.2013 - 12.2013
  • Responsible for component qualification (CQ) activities for new product transfer launch
  • Generate Supplier Qualification to add new suppliers in Approved Supplier List (ASL)
  • Conduct Supplier Audits and Supplier Performance Assessments
  • Develop Component Specifications and Inspection Procedures (IPs) for incoming inspection

Supplier Quality Engineer

Stryker Healthcare
04.2012 - 08.2013
  • Responsible for conducting component validation activities with suppliers. Assess First Article Inspection, Process Control Plans, Process Capability, Gage R&R, Stability Testing and Certificates of Compliance/Analysis.
  • Develop and implement Reduction Testing, Skip Lot and Ship to Stock programs
  • Generate protocols for Validation Plans, Test Method validations, Bioburden/Biocompatibility Testing and Component Qualifications
  • Generate CFMEA’s to determine component’s risk criticality
  • Supplier development to achieve compliance with quality requirements

Aibonito Quality Engineer

Baxter Healthcare
09.2011 - 04.2012
  • Responsible for assuring compliance with Quality System Regulations
  • Participate in Non-conformance Investigations generating and implementing corrective and/or preventive actions
  • Evaluation of customer complaints to implement process improvements
  • Auditing Validations and Protocols of process/equipment
  • In charge of supervising weekend shift plant activities

Education

MBA - Finance

University of Turabo
2019

BS - Industrial Engineering

University of Puerto Rico
2010

Skills

  • Good communication and interpersonal relationships
  • Collaborative team player with leadership abilities
  • Strategic project management planning
  • Highly technical, analytical and detail-oriented
  • Knowledge FDA 21CFR Parts 820, 210 & 211, ISO9001 and ISO13485
  • Computer proficient- Microsoft Office, Project, SAP, Minitab, Trackwise, Master Control, KRONOS, and JDE
  • Fluent in English and Spanish

Certification

  • GMP, GDP, GLP (Standards Knowledge)
  • ASQ Certified Quality Engineer (ASQ CQE)
  • ASQ Certified Quality Auditor (ASQ CQA)
  • Lean Six Sigma Black Belt Certified
  • DMAIC and Kaizen Methodologies
  • DOE (Design of Experiments)
  • Certified Engineer in Training (EIT:NCEES)
  • Certified CAPA Expert
  • Leadership Academy Initiative Certified

Timeline

Advance Quality Engineer (AQE) Lead

BD Humacao
02.2021 - 09.2023

Advance Quality Engineer (AQE) / Sr. AQE

BD Humacao
08.2015 - 02.2021

Quality Engineer and QC Supervisor

BD Humacao (CR Bard PR)
12.2013 - 08.2015

Supplier Quality Engineer

CR Bard Puerto Rico
08.2013 - 12.2013

Supplier Quality Engineer

Stryker Healthcare
04.2012 - 08.2013

Aibonito Quality Engineer

Baxter Healthcare
09.2011 - 04.2012

MBA - Finance

University of Turabo

BS - Industrial Engineering

University of Puerto Rico

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Antonio Rivera Negrón