Allan Rosen

Commack, NY ***** 631-***-**** aczigk@r.postjobfree.com

SUMMARY

Analytical, detail-oriented Quality Assurance Leader with strong communication and problem solving skills, a BEng (EE) and management experience in Medical Device & Aerospace Manufacturing. Experience includes; Quality System Implementation, Process Improvement, Root Cause & Corrective Action, Quality Tools, Statistical Sampling, SPC, FDA-QSR and The Medical Device Directive/CE Marking Regulations

21CFR820

MDD

ISO13485

ISO 9001

CMDR

CAPA

ISO14971

CE Marking

ANSI/ASQ Z1.4

ANSI/ASQ Z1.9

ANSI/ESD S20.20

ANSI/NCLS Z540-3

AS9100

AS5553

AS9102

NAS 412

MIL-PRF-38534

MIL-STD-883

J -STD-001

IPC-A-610

PROFESSIONAL EXPERIENCE

FONAR Corporation, Melville, NY 2017 – Present

FONAR Corporation, the MRI Specialist™, revolutionized diagnostic imaging through the introduction of the world’s first commercial MRI scanner.

Independent Consultant

Revise Quality System Manual & Procedures to comply with ISO13485:2016, FDA QSR 21CFR820, MDSAP and CMDR SOR 98-282.

Plan and execute transition to ISO13485:2016 & Medical Device Single Audit Program.

L-3 NARDA MITEQ, Hauppauge, NY 2006 – 2016

L-3 NARDA MITEQ designs and manufactures a complete line of high-performance components and Satellite Communications subsystems for the RF and microwave electronics industry.

Director of Quality Assurance

Managed a total quality system that included management review, document control, training, customer satisfaction, internal audits corrective/preventive action (CAPA) and process improvement.

Implemented AS9100 Quality System in one year.

Conducted Management Reviews with Senior Management and reported on manufacturing and quality issues including Quality Yields, Trends, and Warranty History.

Performed Root Cause Analysis and implemented Corrective Actions.

Managed and conducted Failure Analysis investigations and issued Failure Analysis Reports.

Negotiated with customers and suppliers to establish contractual quality requirements.

Developed Quality Assurance Plans in accordance with contractual requirements.

Interfaced with aerospace, defense and commercial customers to resolve quality issues.

Implemented Foreign Object Elimination and Counterfeit Parts Prevention programs.

FONAR Corporation, Melville, NY 2000 – 2006

QA Compliance Manager

Managed FDA-Quality System, Regulatory Affairs, EU Medical Device Directive & CE requirements.

Implemented and maintained quality system in compliance with FDAQSR/21CFR820, ISO13485, ISO9001, and CMDR requirements.

Coordinated FDA inspections and Notified Body Audits.

Transitioned to ISO 9001:2000 in less than one year with minimal cost.

Implemented Risk Management system and risk assessments in accordance with ISO 14971.

Managed cross-functional audit team, conducted internal audits, issued CAPAs & Audit Reports.

Reviewed Engineering Changes, Design History Files, Device History Records and FDA 510(k) submissions for QA System and regulatory compliance.

Reviewed customer complaints for adverse events, complaint investigations, trends & FDA MDR.

Developed strategies to comply with Medical Device Regulations and interacted with all levels of company personnel to verify and ensure regulatory compliance.

ALC, B/E AEROSPACE, Inc., Holbrook, NY 1990 – 2000

ALC, B/E AEROSPACE designs and manufactures lighting systems for Business Aircraft.

Quality Assurance Director, (1992 – 2000)

Quality Assurance Manager, (1990 – 1992)

Developed QA system and documentation according to FAA regulations and MIL standards.

Established and maintained productive relationships with customers and suppliers supporting Quality Assurance, Purchasing and technical operations.

Implemented Corrective Action System that improved manufacturing efficiency 25%.

Implemented Vendor Quality System that reduced receiving inspection 30%.

SEDCO SYSTEMS, RAYTHEON ESD Melville, NY 1984 - 1990

SEDCO SYSTEMS, RAYTHEON ESD designs and manufactures antennas for aircraft Electronic Counter Measures systems.

Product Assurance Manager, (1988 – 1990)

ATE QA Test Engineering Manager, (1986 – 1988)

QA Test Engineer, (1984 – 1986)

Organized and coordinated cross-functional teams for developing and implementing corrective action on major electronics manufacturing programs.

Developed and implemented corrective action system utilizing SPC to improve manufacturing processes and yields of electronic circuit card assemblies used in microwave antennas.

Designed and developed S/W and H/W for Automatic Test Equipment (ATE) used in the testing and troubleshooting of back-planes and circuit card assemblies.

Performed system integration and troubleshooting of microwave antennas for Electronic Counter Measure systems.

EDUCATION

Bachelor of Engineering (EE), Magna cum Laude, City College of New York

AAS, Electro-Mechanical Technology, New York City Community College

PROFESSIONAL DEVELOPMENT

Quality Systems 101- Back to the Basics, ASQ Biomedical Division

ISO 9000 Quality Management, Long Island Section, American Society for Quality

RA/QA 101, Regulatory Affairs Professional Society

Developing Executive Leadership, American Management Association (AMA)

Cross-Functional Communications: Strategies for Workplace Effectiveness, AMA

MEMBERSHIPS

ASQ, IMAPS, SAE, IEEE, ESDA

Contact this candidate