Michael Holcomb

Current

Post Market Surveillance at Boston Scientific Neuromodulation

Past

Senior Project Manager at Amgen
Quality Assurance Auditor/Acting Associate Director of Compliance at CancerVax
Black Belt, QA Specialist III at Baxter

QA Supervisor at Pharmavite

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Education

California State University-Northridge

Connections

137 connections

Industry

Biotechnology

Michael Holcomb’s Summary

An American Society for Quality-certified Quality Manager with over 15 years of Quality experience and 11 years of project management experience, including Lean and Six Sigma. Strengths include flexibility as evidenced by being both an independent self-starter and a team player. Intimately familiar with what it takes to succeed in a regulated industry.

Michael Holcomb’s Specialties:

Quality Management, Teaching, Continuous Improvement,System Development, People Development, Data Analysis

Michael Holcomb’s Experience

Post Market Surveillance

Boston Scientific Neuromodulation

(Public Company; 10,001 or more employees; bsx; Medical Devices industry)

April 2008 — Present (1 year 8 months)
Senior Project Manager

Amgen

(Public Company; 10,001 or more employees; AMGN; Biotechnology industry)

January 2006 — October 2007 (1 year 10 months)

Oversaw, managed and coordinated projects of a strategic nature impacting multiple departments and sites. Managed the global quality project portfolio. Provided guidance to project managers and team leaders. Oversaw progress reporting and goal development for quality’s key result areas and forums.
Quality Assurance Auditor/Acting Associate Director of Compliance

CancerVax

(Public Company; 51-200 employees; Biotechnology industry)

October 2004 — October 2005 (1 year 1 month)

Oversaw and managed supplier and internal audit programs. Performed supplier and internal audits. Authored standard operating procedures. Led investigations. Reviewed and interpreted regulations, guidelines and guidance documents. Hosted audits performed by regulatory agencies, customers and consultants.
Black Belt, QA Specialist III

Baxter

(Public Company; 10,001 or more employees; BAX; Biotechnology industry)

February 1998 — October 2004 (6 years 9 months)

Black Belt/DMAIC Champion
Led cross-functional process improvement teams utilizing the tools of six sigma and lean. Mentored green belts. Trained green belt and black belt candidates in DMAIC, six sigma and lean. Implemented DMAIC within the facility.

QA Technical Specialist III
Reviewed and approved exceptions. Owned the deviation notice and discrepancy statement systems. Managed customer complaints. Led project teams. Reviewed and approved validation and material qualification protocols. Led monthly, quarterly and annual management reviews of the quality system.

Compliance Specialist II & III
Evaluated and maintained Divisional supplier compliance program. Performed quality system audits of material and service suppliers globally. Developed divisional policies and procedures for the supplier management program. Managed divisional projects addressing supplier related issues.
QA Supervisor

Pharmavite

(Privately Held; 201-500 employees; Health, Wellness and Fitness industry)

1989 — February 1998 (9 years )

Quality Assurance Supervisor
Supervised a staff including: raw material sampling, production process auditing, final product sampling and auditing, product testing, documentation review, product disposition and document control. Resolved issues found in inspection and review. Identified areas for improvement using tools such as SPC.

Quality Control Chemist I & II

Claims Analyst