Manufacturing/Operations Manager

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Location
Candidate No.
1914863

About this Candidate

DAVRON CV: Candidate 1914863

Manufacturing & Operations Leader | NPI, Lean Six Sigma, Regulated Medical Device Manufacturing

Core Expertise

  • NPI and design transfer leadership across product lifecycle to achieve stable high-quality production
  • Lean Six Sigma-driven continuous improvement reducing scrap, improving yield, and shortening lead times
  • Operational management of multi-shift teams, materials, quality, and safety in regulated environments
  • Supply chain and procurement oversight from sourcing to supplier risk management and cost control
  • ERP-driven production planning and capacity optimization using SAP, Oracle, NetSuite, and QAD

Project Background

  • Led NPI programs, coordinating engineering, quality, and operations to meet launch timelines
  • Managed design transfers and scale-up to larger manufacturing sites including low-cost country transitions
  • Implemented MRB and RMA processes to address non-conformance and reduce scrap costs
  • Directed capacity planning, manpower analysis, and equipment utilization to meet production forecasts
  • Led supplier negotiations, procurement strategies, and end-to-end supply chain sustainability efforts

Key Skills

  • SAP | Oracle | NetSuite | QAD | ERP/MRP systems expertise
  • Lean Manufacturing | Six Sigma | Kaizen | 5S | Poka-Yoke | TQM implementation
  • Regulatory compliance: ISO 13485, FDA CFR820, CGMP, OSHA, and internal auditing practices
  • Cost of Quality | MRB | RMA | Scrap reduction | Yield improvement | QCD management
  • Capacity planning | Production scheduling | Labor efficiency | Machine utilization | KPI monitoring
  • Microsoft Office | Citrix | Excellon | ERP reporting and data analysis

Education

  • General Studies — Luis De Camoes College; completed foundational coursework in liberal studies
  • Computer Operator Certificate — Computer Business College; training in business computer operations and systems
  • High School Diploma — Metropolitan Adult Education School; foundational academic credential

Awards & Recognition

  • ISO 13485:2003 Certified Internal Auditor — BSI Management Systems; certified for medical device quality systems auditing
  • ISO 14001:2004 & 21 CFR 820 Internal Auditor/Assessor — Peak Consulting; environmental and regulatory auditing expertise
  • Total Quality Management certificates including 5S, Poka-Yoke, Kaizen and continuous improvement achievements

Why Interview this Candidate?

A results-driven manufacturing and operations leader with over 20 years in high-mix, regulated industries. Demonstrated ability to lead NPI, design transfer, and scale-up programs while driving Lean Six Sigma initiatives that improve yield, reduce scrap, and shorten lead times. Proven experience managing multi-shift teams, complex supply chains, and ERP-driven production planning to deliver measurable QCD improvements. Well-suited to accelerate operational excellence and compliance in medical device or precision manufacturing environments.

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