Fred Quandee work email
- Valid
- Valid
- Valid
Fred Quandee personal email
Fred Quandee phone numbers
An experienced professional with superior leadership skills with over 20 year experience of delivering outstanding results in Operations and Engineering Management and Quality Regulatory Affairs in domestic and international medical device markets. I am a hands-on manager with expertise in the development of electro-mechanical products for the medical device and commercial products industries as well as managing manufacturing engineering for the support through the product life.I also have over 8 years experience in managing Quality & Regulatory Affairs, with experience in FDA, ISO, Aerospace and Canadian standards. I have a proven record of excelling at multi-department and multiple location challenges, working under intense time, quality and budgetary constraints.
-
System EngineerNovo Nordisk Oct 2021 - PresentBagsværd, Dk -
Operations ManagerWaveform Technologies, Inc., A Agamatrix Holdings Llc May 2018 - Present
-
Quality ManagerTricol Biomedical, Inc. May 2016 - Apr 2018Portland, Or - Oregon, UsManage all Quality systems and product quality for Tricol Biomedical, which develops and markets high performing advanced wound care, hemorrhage, infection control & wound management technologies. Completely restructuring the company's Quality System to better match both the current regulatory environment and the current structure of the company. -
Owner/Consultant: Regulatory And Engineering ManagementQ Technology Oct 2008 - May 2016Some clients include:Westport Medical (Dental surgical device manufacturer): Regulatory Consultant - Created company Quality System, Created manufacturing and purchasing procedures, assisted in setting up and auditing manufacturing linesCommuter City Lights (Commercial Products): Co-founder and technical Project Manager for the development of commercial products.The TOVA Company (Medical - Development of automated testing for ADHD and treatment effectiveness): Developed Quality System and product development procedures for startup medical equipment companyVIA optronics (Aerospace - Manufacturer of ruggedized touchscreen displays for military and aerospace):Updating company Quality System and successfully managing project to achieve ISO 9001Electrochem, Div. of Greatbatch (Medical - manufacturer of custom batteries/battery packs for Medical Industry): Regulatory Consultant - Current
-
Capa ConsultantElectrochem Solutions Inc, A Subsidiary Of Greatbatch Ltd. 2014 - 2015Raynham, Ma, UsI lead the company's response to an FDA Form 483 for deficiencies in the company's CAPA system. Duties included rewriting SOPs for better compliance, reorganizing and leading the CAPA Control Board, and gathering and presenting evidence of compliance to the FDA once new systems were in place. -
Director Of Engineering/Regulatory AffairsGe Security Jan 2005 - Jul 2008Boston, Ma, UsGE Security, a $900M division, develops and manufactures life safety sensors and systems for fire, intrusion, shipping containers coming into the country, and key control markets.Managed Engineering, Regulatory and Document Control departments for the Life Safety Sensors division and Real Estate Key Control division of GE Security, with product lined totaling $300 million annually. Responsibilities also included Document Control for two manufacturing sites and Regulatory Affairs for all American and European companies.• Merged engineering teams at both sites into an efficient cross-functional team which made the most efficient use of the technical abilities of each, resulting in new product introductions totaling $40 million incremental annual sales in the first year. • Led hardware/firmware development of a new cellular based Real Estate key, released in 2007 on time and under budget. New product features caused a greater than expected demand, with $86 million in sales in the first five months. • Partnered with Marketing on strategic growth plans for the Real Estate, Automotive and Commercial product lines for the next 3 years for domestic, European and Asian markets.• Led engineering support for the Tualatin manufacturing facilities, including PCB fabrication, manufacturing test equipment and protocols for component and complete product assemblies for all companies within the division.• Managed document control departments and MRP for engineering of two GE companies with annual saving of $210K. -
Vice President Research & DevelopmentZevex, Int'L. Feb 2002 - Dec 2004UsPublicly held medical instrumentation and component development and manufacturing company with annual revenues of $30 million.Hired to reorganize the Hardware and Software R&D department into an efficient, FDA and ISO compliant development team that met or exceeded customer expectations for quality, schedule and cost. • Reviewed and approved all new product development proposals and performed detailed presentations outlining technical capabilities to prospective customers.• Created Strategic Plan for R&D for 2004 through 2009, to support the corporate Strategic Plan that called for three-time increase in revenue.• Assigned co-leadership role with the Vice President of Operations to implement Lean Manufacturing and process improvements on all product lines. Lean Manufacturing training was completed, and within 8 month had main product line, with its entire inventory, converted to Lean. This resulted of a reduction of assembly time by more than 1/3 and with improved quality, evidenced by a reduction in rework and improved final test numbers.• Initiated rewrite of the company Quality Policy and Procedures. Reduced 93 Quality/Development procedures to 26 that were compliant, clear and easily adhered to.• Increased the number of OEM products taken from development into manufacturing from a previous maximum of two systems projects in any one year to nine completed products. -
Director Of Program ManagementVia Medical (Aka Metracor) 1997 - 2002Biotech Company involved in development and manufacture of Class 3 point of care, patient attached blood gas monitors and its disposable biosensors, used primarily in Operating Rooms and Intensive Care units.Managed and established product vision, specifications and was ultimate project manager of all new instrumentation products. • Implemented Manufacturing & Quality Systems necessary to meet ISO-9001/ GMP guidelines. Successfully completed ISO9001 certification audits one year ahead of schedule.• Directed Software and Hardware Engineering departments with staff of 12 for new product development• Created and implemented developmental SOP’s that both complied with FDA guidelines and created a more efficient development process.• Developed the project plan, schedules, budgets, and staffing requirements and contracted outside design companies for a $9 million, 3-½ year development program of the new generation monitor (FDA Class 3 device). FDA granted 510(k) clearance in 2001.
Fred Quandee Skills
Fred Quandee Education Details
-
California State University-SacramentoBiological Science -
California State University-SacramentoMechanical Engineering
-
Keller Graduate School Of Management Of Devry UniversityMarketing & Finance
Frequently Asked Questions about Fred Quandee
What company does Fred Quandee work for?
Fred Quandee works for Novo Nordisk
What is Fred Quandee's role at the current company?
Fred Quandee's current role is Engineering and Quality Systems Consultant.
What is Fred Quandee's email address?
Fred Quandee's email address is fq****@****isk.com
What is Fred Quandee's direct phone number?
Fred Quandee's direct phone number is +180126*****
What schools did Fred Quandee attend?
Fred Quandee attended California State University-Sacramento, California State University-Sacramento, Keller Graduate School Of Management Of Devry University.
What skills is Fred Quandee known for?
Fred Quandee has skills like Design Control, Medical Devices, R&d, Sensors, Six Sigma, Testing, Product Development, Engineering Management, Engineering, Management, Leadership, Quality System.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial