Dennis Mulrane

*** ***** ** 201-***-****

Franklin Lakes, NJ 07417 ac8ti8@r.postjobfree.com

CAREER SUMMARY

Operations executive with manufacturing and quality assurance experience in large, small and multiple site companies manufacturing automotive, medical and industrial products. Recognized for the design and implementation of world-class operational procedures, methods and systems. Technical expertise in electro/mechanical assembly and plastic fabrication consistently leading to improved earnings. Strong hands on leader with a unique combination of business skills and experience in technology, manufacturing and computers. Demonstrated expertise and accomplishments in:

LEAN Manufacturing (TPS)

Six Sigma/5S/6S

Process / Product Validation

Building Enterprise Value

Team Building

Productivity Improvement

Strategic and Tactical Planning

Risk Management ISO 14971

Regulatory Affairs

Project Management

CAPA

Cleanrooms

Supply Chain Optimization

Value Stream Mapping

Sterilization

FDA QMS ISO 13485

Supplier Quality

Auditing

PROFESSIONAL EXPERIENCE

Carl Stahl Sava Industries January 2016 to March 2019

Manufacturer of Precision steel stranded Cable, Cable assemblies’ uses in medical devices

Director of Manufacturng

Responsible for the Manufacturing, Production Control, Logistics and Quality Departments.

Lead Continuous Improvement Programs and creation of Production Cells

Implemented SPC and Paperless Quality Management Software.

GE Healthcare, Vital Signs / Carefusion / BD May 2013 – December 2015

Manufacturer of Class I and II Medical Devices - Anasthesia Circuits and Temperature Monitoring Devices.

Senior Site Quality Leader (Site Director)

Responsible for Quality Assurance, Quality Control and Regulatory Affairs

Management Rep

Created, Documented and Implemented a QMS in compliance to ISO 13485 and 21 CFR 820

Created Manufacturning Procedures and Work Instructions supporting QMS requirements

CAPA Leader, Lead Internal Auditor, Creator of Quality Goals, Complaint Management, Regulatory filings.

GE Healthcare, Omnyx LLC June 2009 – May 2013

Manufacturer of Class II and lll Medical Devices (Software and Hardware) for the Digital Pathology Industry.

Director Manufacturing and Qualilty Assurance Feb 2010 to 2013

Management Rep

Created, Documented and Implemented a QMS in compliance to ISO 13485 and 21 CFR 820

Created Manufacturning Procedures and Work Instructions supporting QMS requirements

Created and facilitate Management Reviews.

Manufacturing Manager June 2009 – Feb 2010

Developed and documented manufacturing processes under 21CFR Part 820

Crated IQ/OQ/PQ documents for process validations (PFMEA)

Installed ERP software and populated all modules

Created Solidwords PDM environment for design specification control

Created Engineering Change Control process.

GE Healthcare, Wave Products Group Somerset, NJ October 2004 – October 2008

Manufacturer of Wave Bioreactors and sterile disposable cellbags for the Biotech and Pharmaceutical industries.

Director Operations – May 2006 to October 2008

Monitor, control and lead the manufacturing, quality assurance, purchasing and logistic departments to support the Wave bioreactors.

Complex manufacturing processes include PCB, Assembly, Harness, testing and Class 10,000 cleanroom manufacturing.

Creation and control of Class 10000 Cleanroom for the manufacture of sterile disposable products.

Project manager for the implementation of JDE/Oracle ERP Systems.

Utilized and trained lean six sigma manufacturing techniques in a critical fast pace manufacturing environment.

Built company image by collaborating with customers, government, and employees; enforce ethical business practices.

Accomplished objectives by establishing plans, budgets, and result measurements; allocating resources; reviewing KPI progress; making mid-course corrections.

Director Quality Assurance October 2004 to May 2006

Validation of the equipment, process and environment for the manufacture of disposable Cellbags.

Supplier monitoring of sterile disposable products.

Implementing Quality Management System to support FDA 21CFR820, ISO9001 and ISO13485 requirements.

Creation of Disposable Drug Master File (DMF), IQ/OQ/PQ documentation.

Product/Process Validation for Sterilization.

Almetek Industries Hackettstown, NJ January 2004 to October 2004

Manufacturer of Industrial signs and Labels. Manufacturing processes include stamping, CNC engraving, screen printing, thermoforming and assembly with 6 Million dollars in sales.

General Manager – Reporting to the President.

Complete responsibility for Operations, Logistics, Engineering and new product development.

Implementing Lean Manufacturing Methodologies to improve on time deliver and product quality.

NJ Manufacturing Extension Program, Inc. Newark, NJ June 2003 to December 2003

Quality Systems and Lean Manufacturing Methodology Technical Consultant. Contract position to assist small to medium sized manufactures in New Jersey to improve their systems and to assist in resolving operational issues. Lean Methodology and Quality Management System (ISO, AS, TS and FDA 21CFR820) implementation and training.

Tinnerman Palnut Engineered Products, LLC. Mountainside, NJ February 1999 to March 2003

$110 million manufacturer of highly engineered, precision assemblies and spring steel fasteners consisting 650 employees and four facilities. This company was created by merging divisions of Eaton Corporation and TransTechnology Corporation; a tier one supplier to Fortune 500 companies including Mattel, GE, Ford, GM, Daimler-Chrysler, Toyota and Rubbermaid

Vice President of Operations - Reporting to COO in Brunswick, OH. July 2000 to March 2003

Complete P & L responsibility for an operation with $35MM in sales, 144,000 square feet facility. Processes include stamping, tapping, heat-treating, plating, painting, and assembly utilizing batch processing.

Functional accountability included Manufacturing, Logistics, Finance, Engineering, MIS and Human Resources and Sales Support.

KPO responsible for implementation of lean manufacturing concepts for improved process flow, reduced lead times and inventory reduction through Kaizen events.

Created strategic plans, operating plans and fiscal budgets.

Major accomplishments:

oIntroduced lean manufacturing methodology utilizing Value Stream Mapping, Kaizen, 5S, TPM, QCO events. Conducted 18 Kaizen events in twelve months.

oReduced inventory from $6MM to $3.2MM in two years.

oReduced product lead-time in major product line from 56 days to 24 days.

oNegotiated UAW union contract leading to a decertification process.

oReduce Premium freight by 60%.

oReduced product scrap by 70%.

oTrippled Operating Income in two years.

oParticipated in sale of company in December 2001.

Director Quality Assurance February 1999 to July 2000

Reduced customer complaints by 60%.

Obtained QS 9000 Certification.

Introduced Lotus Notes paperless document flow and record retention.

Introduced problem solving and root cause analysis techniques for corrective action resolution.

Created PPAP, FMEA and Control Plans for part submission.

American Products Company, Union, NJ Oct. 1996 to January 1999

Manufacturer of precision CNC machined products for the Military, Automotive and Commercial Industries with over $10MM in sales.

Director Quality Assurance

Reported to President. Responsible for ten-person quality assurance organization.

Management Representative for the Quality System, ensuring compliance to ISO 9002, QS9000, Military and Commercial standards.

Implemented Lotus Notes software for email and paperless quality system.

Reduced customer returns by 80% by introducing documented final inspection plans, inspection techniques and trained personnel.

Key member of implementation team for Visual Manufacturing (ERP) business systems software.

Conduct training programs on ISO/QS 9000, SPC and measurement techniques.

Obtained external funding grants to train all employees in a variety of disciplines.

Reduced scrap as a percent of sales from 5% down to 0.2% by use of MRB.

Prepare PPAP documentation including Control Plans, DFMEA, PFMEA and Gage R and R

Whatman Inc., Clifton, NJ May, 1993 to Oct. 1996

International Chromatography and Filtration Device Manufacturer including HPLC, TLC, Syringe Filters, Laboratory Air Filters and Silica based separations with over $50MM in sales.

Quality Assurance / Regulatory Affairs Manager North America

Reported to VP Operations (England). Led up to 15 person Quality Organization.

Implemented a quality system that complies with ISO 9001 and FDA 21CFR820 / GLP requirements for three facilities located in New Jersey and Massachusetts.

Advanced to regional QA Manager of 4 locations, two in NJ and 2 in Massachusetts.

Product non-conformances were reduced by 50 percent.

Customer returns and complaints reduced by 30 percent within one year after implementation of root cause analysis and problem-solving techniques.

Camloc Products, Div. of Fairchild Industries. Hasbrouck Heights, NJ September 1986 to May 1993

$20 million manufacturer of highly engineered specialty fasteners for the aerospace, automotive and commercial industries.

Director of Quality Assurance

Reported to General Manager with input to VP QA Fairchild. Led twelve-person quality assurance organization.

Implemented a Quality System and Total Quality Management Program leading to accreditation by the Ford Motor Company (Ford Q1 award).

Created and implemented procedures meeting the requirements of MIL-Q-9858, MIL-I-45208, FDA GMP, MIL-STD-45662, Ford Q1, GM Targets for Excellence, Boeing D1-9000, ISO-9001, HR3000 Fastener Quality Act.

Installed Statistical Process Control system utilizing a 16-computer network with a real time management hub for analysis. Created and issued a SPC Plan for customers.

Obtained certifications to Ford Q1, General Dynamics SPC, Mil-I-45208 and Mil-Q-9858.

Achieved approved supplier status to 12 of the 14 Malcolm Baldrige Award winners.

Conducted product problem solving utilizing DOE and Failure Mode Analysis.

Stamping Operations Manager (Special Assignment- Continuous Process Improvement)

EDUCATION and MEMBERSHIPS

B.S. Business Management, Farleigh Dickinson University

Certified Lead Quality Auditor – GE Healthcare 2013

SSBB – GE Healthcare

21 CFR Part 820 Training: EMERGO Group 2010, ComplianceWire 2012

ERP/MRP Training and Installation

SPC / Six Sigma seminar conducted by IBM Corp.

Logistical Data Modeling

Lean Manufacturing Methodology, Value Stream Mapping, 5S, QCO, Cellular Manufacturing, Total Productive Maintenance (TBM/NJMEP) and NIST Certified.

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