Quality Engineer Independent Contractor
Resume:
Douglas Adams
Saint George, UT *****
*********@*****.***
Work Experience
Independent Contractor - Spanish Fork UT
June 2014 to June 2014
Quality Engineering Responsibilities and Duties.
· Sabbatical (Care for Family)
· Independent Contractor
Quality Engineer and Quality System Oversight.
ATL Technologies, Inc. - Springville UT
May 2011 to June 2014
· Drive corporate certifications. Provide constant surveillance.
· Coordinate with China facility for product and certifications.
· Advise Design Teams of design phase requirements.
· Lead Controller for Quality System duties and responsibilities.
· Communicate internal and external (field failures) process per QSR’s.
· Drive Management Review.
· Approve IQ, OQ, PQ.
Corporate Quality Engineer: (Corporate Level Staff Reduction) DTI Inc. Lab Network - Dublin CA, Draper UT
October 2008 to December 2011
· Drive corporate certifications. Provide constant surveillance at corporate headquarters in Dublin California. Identify trends to management.
· Corporate trainer for regulations and procedures.
· Provide knowledge and awareness for roles/responsibilities for all levels.
· Ensure connectivity of personnel at all levels, functions, and locations. Compliance/Quality Specialist
Cephalon Inc. - Salt Lake City, UT
September 2007 to September 2008
Left for position/role with more responsibilities (DTI Corp Quality Engineer) Enhanced QMS for 21 CFR, GMP, DEA, ISO 13485 & 9001
· Critical disciplines/responsibilities identified/presented to Senior and Middle Management. Used internal audits, weekly reviews and one-on-one meetings with department/process owners.
· Travel for supplier audits, Host all external audits.
· Internal and external auditor. Create metric systems. Incoming Quality Assurance Manager.
Merit Medical Inc. - South Jordan, UT
September 2006 to September 2007
Left position/role for more responsibilities.
· Manage all products from multiple facilities. Assist Engineering resolution for product issues and trends.
· Ensure testing, inspection, and procedures meet requirements and standards.
· Create or assist in corrective/preventive action response. Team member.
· Conducted supplier audits. Assist teams in providing quality system expertise for acquisition of various companies.
· Responsible for all inspection personnel and material, defect disposition and trending.
· Maintain compliance to domestic and international standards. Provide timely response for all manufacturing defect trends.
· Supplier Quality Auditor. Qualify, trend, and perform surveillance audits.
· Create, update and improve controlling documentation. Material Review Board (MRB) Chairperson (Re-hire at GE OEC- Quality Department)
GE OEC Medical Systems Inc. - Salt Lake City, UT
September 2004 to September 2006
· Directed eight-person committee in review of defective material. Communicate issues and provide connectivity.
· Identify disposition of defective material (Production, Manufacturing, Engineering, and Field Service)
· Provide connectivity and prioritization for Production, Manufacturing, Engineering, and Field Service deadlines, issues and trends.
· Provide trending and data and reports to management.
· Maintain clear and concise records in all internal and corporate databases.
· Communicate results to team.
GE OEC Reduction of Force: Self Employed as Quality Consultant. Lead Quality System Auditor/Regulatory Engineer
GE OEC Medical Systems Inc. - Salt Lake City, UT
February 2004 to September 2004
Jan. 2000 to Feb. 2004
· Perform all internal/supplier. Submit quality metrics to Senior Staff monthly in Quality Management meeting.
· Completed facility certification for ISO 9001, ISO 13485 and Canadian Medical Regulation.
· Staff for Global Audit Council responsible for worldwide compliance.
· Regulatory signature authority. Reviewed all ECN’s for accuracy and Critical Components.
· Manage/maintain internal audit program. Communicate audit results to Senior Management.
· Organize/host external audits.
· Full quality system audits of sister facility.
· Supplier qualification and surveillance audits
· Design Control review.
Regulatory Engineer/Quality System Auditor
OEC Medical Systems Inc. - Salt Lake City, UT
March 1999 to January 2000
Education
BSBM
University of Phoenix
BSBM
Salt Lake Community College
Bountiful High School
Contact this candidate