Quality Assurance Engineer

JOEL B. SANDBERG

Lake Worth, Florida ******@*****.*** 561-***-****

QUALITY ASSURANCE ENGINEER

Quality Assurance Engineering Risk Management Staff training

Manufacturing Engineering Compliance to regulations

Audit internal, vendor operations CAPAs and complaint resolution

Develop quality programs Inspection and test planning

CERTIFICATIONS

American Society for Quality (ASQ):

Certified Quality Engineer (CQE) Certified Reliability Engineer (CRE)

Certified Quality Auditor (CQA) Certified Software Quality Engineer (CSQE)

PROFESSIONAL EXPERIENCE

MAKO SURGICAL, Ft. Lauderdale, FL 2006 2012

Manufacturer of robot for orthopedic surgery

Senior Quality Assurance Engineer

Reviewed and approved resolution and closure of 1400 complaints and 560 CAPAs per year.

Resolved production problems in design documents, manufacturing methods and purchased components.

Designed, programmed, trained 200 users, rolled out and administered CATSWeb ® system to track all

complaints and CAPAs, preparing 35 charts monthly, identifying trends and the most significant issues.

Developed, implemented and ran the CAPA review board process, overseeing the escalation of issues to

formal, in depth CAPA investigations.

Insured that engineering and manufacturing drawings, assembly instructions, test protocols and data met

ISO, IEC, FDA and project requirements.

Approved first 23 robotic systems for shipment, including review of device history records and all test and

inspection results.

QUANTACHROME INSTRUMENTS, Boynton Beach, FL 2003

2006

Manufacturer of particle measurement instruments

Quality Assurance Engineer

Audited quality policies, procedures and instructions to maintain ISO 9000 certification.

Trained five test technicians and two inspectors.

Ran MRB and approved closure of 50 to 100 non conformances each month.

Developed and implemented Product Registration /Quality Survey to collect customer feedback.

Wrote and updated test instructions for new and improved Autosorb ®, NOVA®, PoreMaster® and UltrapycTM

material porosity measurement instruments.

DATASCOPE, Mahwah,NJ 1995 2003

Manufacturer of medical patient monitors for hospitals

Senior Quality Assurance Engineer

Managed quality assurance activities for Accutorr® patient monitor and Viewpoint central station projects.

Wrote product specification and wrote and ran validation protocols for Accutorr medical patient monitor.

Developed, executed and reported on 1200 page validation of Viewpoint system.

Wrote Accutorr clinical test protocol and trained clinicians at two hospitals.

Audited internal projects and vendor's quality system.

Prepared risk management summary/hazard analysis for Accutorr and Viewpoint projects.

Reviewed and approved product design specifications, user’s manuals, drawings, test procedures and results

for compliance with FDA regulations, UL, CSA, IEC and en standards for medical devices.

EDUCATION and PUBLICATIONS

M. S., Computer Hardware and Software Systems, Fairleigh Dickinson University, Teaneck, NJ

B. S., Electronics Engineering, Cum Laude, Northeastern University, Boston, MA

"Quality Data: Database Management Systems and QA Applications,"

Quality engineering magazine, Marcel Dekker, Inc.

"Reliability for Profit, Not Just Regulation,"

Quality Progress Magazine, American Society for Quality Control

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