To whom it may concern,

My career objective is to remain a significant contributor to the Medical Device or Pharmaceutical industry, or in a closely related industry that will benefit my cGMP background. I seek an environment where I can significantly contribute to products that will improve people’s quality of life and longevity.

I have enjoyed a very successful career, which has afforded me a broad amount of experience. Most recently, centered on Quality Assurance and Regulatory Affairs, and on Project Management just prior to that. My earlier years were formed running extensive qualification programs in the aerospace industry. I worked eight years focused on Department of Defense work, and an additional eight years focused on the International Space Station. For the last fifteen years I have been exclusively devoted to the medical device industry. I have focused on both product development and manufacturing, with extensive validation work (PMA & 510(K) submissions and approvals) and project management in both arenas. I have excelled in this industry, achieving promotions in each of the last three companies I have worked for. This has been the result of my leadership skills, commitment to team work, planning and organizational skills, and understanding the necessity for concise communication and the management of expectations.

I have supplemented my education earning my Six Sigma Green Belt Certification from Villanova University as well as Project Management Certification from Rutgers University. Additionally, I hold two professional licenses.

I believe that my work history, coupled with the promotions I have received, clearly demonstrate my ability to be a significant asset to your organization, and I ask for the opportunity to contribute to your goals.

Thank you,

John D. McCarren

201-***-****

acunl5@r.postjobfree.com

JOHN D. MCCARREN Page 1 of 2

201-***-****, acunl5@r.postjobfree.com

SUMMARY: Over 25 years of experience focused in the Medical Device and Aerospace industries:

Manage Quality Assurance and Regulatory Affairs departments for start-up Medical Device Company.

Project Manager with proven ability to complete projects on time and within budget.

Experienced manager driving development of personnel and building cohesive team environments.

Strong knowledge of operations within FDA, EU MDD, FAA & DOD regulated environments.

Experienced in product development, prototyping, production improvement, and process development.

Technical writer with extensive experience in Validations, IQ/OQ/PQ’s, FMEA’s, ECN’s, SOP’s, MRB, & CAPA’s.

Exemplary troubleshooting skills; quickly assess problems & implement timely & effective solutions.

Experience in mechanical & electrical design & testing, experience with 3D-CAD modeling using SolidWorks, with emphasis on manufacturing equipment & processes.

Auditor trained in ISO 13485, 21 CFR Part 210, 211, & 820, and European Commission MEDDEVs (EU MDD).

Successfully lead audits with FDA, Notified Bodies, clients & customers, vendors & contract manufactures.

EXPERIENCE:

Aerotek Somerset, NJ

Contract Project Management 11/15 – 02/16

Contract position for project management in SEMI Conductor industry. Set up project schedules, establish requirements, drive design reviews, manage contract manufactures, and present progress reports.

MELA Sciences Irvington, NY

Director of QA & RA 11/13 – 09/15

Overhaul QMS SOP system, streamlining procedures to align with business needs while improving compliance to 21 CFR Part 210, 211, & 820, ISO 13485, ISO 14971, and EU MDD.

Update CE Technical File resulting in successful audit and recertification from Notified Body (BSI).

Set up complaint trending system, managed MRB and prioritized NCR’s to maintain production schedules.

Manage PMA annual reports and Supplements (30-Day, 135-Day, 180-Day, & Real Time submissions).

Overhaul Product Development & Design Control process, improving regulatory compliance and time to market.

Managed personnel providing training, team building, performance & career assessments, & disciplinary actions.

Senior Project Manager 04/13 – 11/13

Initiated Project Management Office (PMO) for a startup medical device company.

Manage multiple projects for all departments; Operations, Engineering, R&D, Marketing, Sales, Clinical, Customer Support, Finance, and Human Resources, significantly improving timeline & budget targeting.

Implemented cost reduction & process improvement projects, reduced costs by 23% and process time by 75%.

Alfa Wassermann West Caldwell, NJ

Project Engineering Manager (Diagnostic Technologies Division) 08/08 – 12/12

Successfully headed hardware development project to launch next generation clinical blood analyzer.

Managed all aspects of project execution, from Concept & Design through Procurement, Prototyping, Validation (510(K) submission and approval), and transition into Production, including Operations support with SOP’s, Process Specifications, and Production Routers within MRP system.

Responsibilities encompassed defining requirements, including budgeting & costing, technical specifications, resource allocation, managing personnel, vendor evaluation & selection (including cost negotiations to maintain budget goals & vendor audits), inventory control & production scheduling for pre-production builds.

Worked across all disciplines, Quality/Regulatory, Sales/Marketing, Finance, Purchasing, & Operations.

Lead Kaizen team improving production process flows and driving cost reduction program.

Served as an Internal Auditor trained in ISO 13485 & 21 CFR Part 210, 211, & 820, MRB & CAPA Team Leader.

Project Engineer (Separation Technologies Division) 11/06 – 08/08

Managed multiple product development projects simultaneously. Ensured customer expectations were met by coordinating with customers, vendors, and senior management to drive resolutions to unanticipated problems. Determined project requirements, including GAMP & NEC, prioritized work assignments and oversaw vendor deliverables. Established validation and documentation needs; generated drawings, P&ID schematics, BOM’s, and Assembly Procedures.

Managed cost improvement program (reduced vendor costs by 28% from FY07/08), supported Quality functions ensuring meeting of certification requirements for CE, ISO, & FDA, & support of quality audits.

Managed Engineering Personnel including workloads, career assessments, and performance reviews.

JOHN D. MCCARREN Page 2 of 2

Datascope Corporation Mahwah, NJ

Senior Engineer (Interventional Products Division) 11/00 – 10/06

Manufacturing Engineer for a medical device manufacturer specializing in interventional products and collagen based vascular sealing. Began as Engineer II in November 2000, promoted to Engineer III in October 2002 and promoted to Senior Engineer in May 2005.

Managed Junior Engineers, Technicians, & Internship Program, personnel reviews & career coaching.

Completed Leadership Training program including Influencing for Results, Managing Conflict, Situational leadership, Coaching for Performance, and Negotiating Skills.

Trained auditor supporting QA with internal, vendor, and FDA audits (ISO 13485 & 21 CFR 210, 211, & 820).

Overhauled & managed Equipment & Facilities Maintenance Program to GMP & OSHA requirements.

Designed, modified, & updated robotic automated equipment, encompassing electronic, pneumatic and mechanical elements, improving productivity & providing cost savings.

Wrote programs for PLC’s, user interfaces, and robotic controllers and qualified software programs by designing and performing “White Box” software validations.

Wrote & executed over twelve validation protocols, with final reports within a two year period, allowing new equipment to be qualified & a new product line to launch on schedule.

Managed new equipment procurement, including researching and directing vendors, capital appropriations requests, project planning, and validation.

Lead liaison to main component supplier for primary product line, initiated quarterly review meetings, improving relations & communications, resulting in quicker solutions to component & vendor issues.

ASCO Controls Florham Park, NJ

R&D Test Lab Technician 05/00 – 11/00

Responsible for UL-Certified Lab testing programs. Ran qualification programs involving automated life endurance and vibration testing. Proficient with data acquisition software and PLC programming.

Yankee Corporation Bronx, NY

Plant Maintenance Manager 09/99 – 05/00

Installed and maintained equipment for retail/export soft goods Corporation.

Designed layout and installation of Single and Three Phase electrical service: Indoor/outdoor lighting, power distribution outlets and ventilation systems. Plumbing systems: Industrial gas & water heaters, & drain systems. Factory machinery: Bailing presses, forklifts, computer, phone, and security systems.

ARDE, Inc. Norwood, NJ

R&D Lab Lead Technician 05/91 – 08/99

Responsible for initial set up & operation of R&D Lab for the International Space Station, focused on high-pressure gas systems for manned flight. Generated lab reports & documentation. Assessed test requirements, wrote procedures, trained & supervised lab personnel. Design and fabrication of both a thrust measurement system and a mass flow measurement system for two-phase fluids. Proficient with helium spectrometer leak testing, high-pressure cryogenics, & hi-vacuum technology. Supervised & maintained operation of Class 100 Cleanroom. Initiated, & maintained calibration tracking system.

Teledyne Hydra-Power New Rochelle, NY

Aerospace Engineering Technician 05/83 – 05/91

Ran Safety of Flight and Qualification test programs for aerospace components, sub-contracting to the DOD. Managed endurance, impulse & environmental testing for both R&D and production departments. Significantly improved production output via updating of electronic instrumentation and incorporating automation of hydraulic test systems. Maintained documentation, workload schedules and inventories.

EDUCATION:

Villanova University, Villanova PA, Certified Six Sigma Green Belt

Rutgers University, New Brunswick NJ, Certified Project Manager

College of Aeronautics, Queens, NY (Vaughn College of Aeronautics & Technology)

Graduated Summa Cum Laude with a grade point average of 4.00 earning a Degree in Aeronautical Engineering. Winner of the Founders Award for Academic Achievement.

Teterboro School of Aeronautics, Teterboro Airport, NJ

Graduated 2-year intensive training program with a CPA of 87%, earning FAA Airframe & Powerplant licenses.

Monroe Community College, Rochester, NY

Majored in Mechanical Technology/Auto Visual Technology. Dean’s List.

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