Engineer Quality

Rose Lerer

* ******* **. **********, ** *****

978-***-**** (H) 978-***-**** (C) *********@*******.***

SUMMARY

Experienced Quality Engineer with experience in the medical device industry.

SKILLS AND EXPERIENCE

Quality Systems.

oDeveloped the following quality systems: document control, training, tool control, product identification and traceability, purchasing controls, design reviews, design output, and design verification. Authored procedure to define a system for reviewing the effect of new and revised standards.

oConducted training on quality issues, including an introduction to quality for new employees.

oAdministered training, document control, tool control, and complaint handling systems.

oWrote and implemented a quality plan to address quality issues related to facility relocation.

oSpecified and validated custom complaint handling software application. Served as QA liaison to IT and users for this project. Solicited user input for specification and conducted training on the final application. Project resulted in an elimination of approximately 8 hours per week of data entry time compared to the previous manual system. It also improved the efficiency and visibility of the complaint evaluation process.

oProcessed nonconformance records and CAPAs.

oManaged ISO 9001 implementation project for touch screen manufacturer. Conducted internal audits and coordinated efforts of volunteer auditors.

oValidated calibration management software and coordinated its implementation.

New Product Introduction:

oManaged design history files. Proactively solicited deliverables required to demonstrate compliance with design control requirements of FDA Quality System Regulation and ISO 13485.

oReviewed and approved design input documents, plans, protocols, reports, drawings, BOMs and specifications.

oCoordinated design reviews. Ensured that reviews were properly documented and that action items were completed.

oParticipated in risk assessments and usability discussions.

oProvided Quality Assurance support for the development of automated hematology analyzer and its consumables.

oParticipated in an interdisciplinary team to transfer reagents from development lab to high volume manufacturer. This included review of all specifications, process validation documents, and gage R&R reports as well as participation in frequent phone meetings with the manufacturer.

oCollaborated with others to create a reagent stability testing process that includes all stages (initial stability testing to stability surveillance) and all applicable activities (e.g., transport stability, shelf life, in-use stability, antimicrobial testing).

Labeling:

oDeveloped specification on labeling content requirements.

oUpdated design input and output to incorporate unique device identifier requirements.

oReviewed labeling to ensure compliance.

Manufacturing/Industrial Engineering.

oProvided hands-on support to the electromechanical assembly and sensor assembly areas for a manufacturer of medical analyzers. This included representing manufacturing at MRB and product line quality committee meetings, and participating in projects to improve productivity and decrease lead time.

COMPANIES

Roche Diagnostics Hematology, Inc. Westborough, MA Quality Assurance Engineer

Cytyc Corporation (now part of Hologic) Boxborough, MA QA Specialist

Boston Scientific Corporation Mansfield, MA Industrial Engineer

MicroTouch Corporation Methuen, MA ISO 9001 Project Coordinator

Nova Biomedical Corporation Waltham, MA Manufacturing Engineer

EDUCATION

Boston University

BS, Manufacturing Engineering

INTERESTS

Current member of church governing board. Also serve on membership and policies and procedures committees and accessibility design task force.

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