Quality Assurance Manufacturing Engineer
Resume:
Dennis Mulrane
Franklin Lakes, NJ 07417 ********@*******.***
CAREER SUMMARY
Operations executive with manufacturing and quality assurance experience in large, small and multiple site companies manufacturing automotive, medical and aerospace defense products. Recognized for the design and implementation of world-class operational procedures, methods, and systems. Technical expertise in electro/mechanical/optical 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
ISO 9001, AS9100, TS16949
Team Building
Security ITAR Requirements
Strategic and Tactical Planning
Risk Management ISO14971
Regulatory Affairs and EHS
Project Management
CAPA
Cleanrooms /Sterilization
Supply Chain Optimization
Value Stream Mapping
Calibration - MSA
FDA QMS ISO 13485
Supplier Quality
Auditing
PROFESSIONAL EXPERIENCE
TAM Metal Products May 2023- July 2024
Manufacturer of Machined and Sheet Metal products for the Aerospace and Medical Industries.
Quality Assurance Manager
Lead and mentored the implementation of the Quality Management System for compliance to NADCAP and AS9100
CACI / LGS Innovations / Wireless Solutions/ Photonics June 2019 to May 2023
Sr. Quality Leader
Lead and mentored the implementation of the Quality Management System for compliance to AS9100 leading to CACI Certification by NQA
Created procedures supporting all clauses of AS9100 including Document Control, Internal Audits and Calibration, Management Reviews.
Designed QMS processes for FRACAS using Arena PLM Software
Participated in AS9100 Certification for multiple divisions.
Supported Quality participation in design and development programs,
Security Clearance requirements
Direct labor support of program quality requirements
Carl Stahl Sava Industries January 2016 to March 2019
Manufacturer of Precision steel stranded Cable, Cable assemblies’ uses in medical robotic devices
Director of Manufacturing
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 - Anesthesia Circuits and Temperature Monitoring Devices.
Senior Site Quality Leader (Site Director)
Responsible for Quality Assurance, Quality Control and Regulatory Affairs
Management Rep maintain certification to ISO13485 with International Registrar TUV
Created, Documented, and Implemented a QMS in compliance to ISO 13485 and 21 CFR 820
Created Manufacturing Procedures and Work Instructions supporting QMS requirements.
CAPA Leader, Lead Internal Auditor, Creator of Quality Goals, Complaint Management, Regulatory filings.
Managed compliant calibration and preventive maintenance processes.
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 Quality Assurance Feb 2010 to 2013
Management Rep
Created, Documented, and Implemented a QMS in compliance to ISO 13485 and 21 CFR 820
Created Manufacturing 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 Epicor ERP software and populated all modules.
Created SolidWorks PDM environment for design specification control.
Created electronic Engineering Change Control process using SolidWorks PDM.
GE Healthcare, Wave Products Group Somerset, NJ October 2004 – October 2008
Manufacturer of Wave Bioreactors and sterile disposable cellbags for the Biotech Vaccine 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-paced 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) filed with the FDA and IQ/OQ/PQ documentation.
Product and 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 of 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, Boeing, General Dynamics, 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%.
oTripled Operating Income in two years.
oParticipated in the 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 Department of Defense, Automotive, Areospce 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 percentage 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
Coordinated DCAS Source Inspection per government contracts.
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 a 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 were reduced by 30 percent within one year after implementation of root cause analysis and problem-solving techniques.
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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