Operations and Quality Systems Efficiencies Consultant Resume

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Operations and Quality Systems Efficiencies Consultant

Confidential

Responsibilities:

Audited entire Quality Management System (QMS) formally documenting all findings
Investigated all findings to root cause and implemented permanent corrective actions for 100% of findings.
Wrote\rewrote SOPs that were inadequate\ineffective relating to the quality systems as well, in addition wrote specific process operations procedures.
Implemented internal auditing role
Restructured entire organization, generated corporate organization chart, and wrote job descriptions for the management team reporting to the president
Introduced and implemented Key Performance Indicators (KPIs) for all meaningful quality and operations processes
Revised Documentation Control\ECO process to be more complete and controlled and to allow for appropriate review and feedback before change is released
Improved overall quality from 60% to well into the 90% range as the result of the above actions

Materials and Supply Chain Manager

Confidential

Responsibilities:

Responsible for vendor relationships and negotiating terms of business from COD to 30 days. Work with Legal to finalize non-standard terms of contracts and formal Manufacturing Service Agreements.
Generated and managed the Master Production Schedule and Materials Requirements Planning from Sales and Operation output for short term and long term planning ensuring appropriate inventory coverage at all levels.
Performed Supply Chain Risk Analysis and Mitigation ensuring 100% material coverage.
Managed all shipping, receiving, purchasing and logistics functions.
Modified or created all department policies and procedures consistent with FDA and ISO requirements.
Work closely with Finance for all month end closing processes as well as inventory management requirements.
Managed four direct reports.
Identified and qualified a Chinese CMO and managed the Supply Chain and Logistics functions as necessary
Drove the selection and implementation of the ERP System (QAD - Mfg\Pro).

Materials and Manufacturing Manager

Confidential

Responsibilities:

Transitioned engineering designs into manufacturing for multiple products
Transformed manufacturing from a cubicle to an FDA compliant production work site
Generated all production and purchasing SOPs
Established all raw material suppliers and created manufacturing agreements with each
Went through an FDA audit with zero findings in my area of responsibility