Fred Quandee Email & Phone Number

Bagsværd, DK

Portland, OR - Oregon, US

Manage 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.

Some 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.

Raynham, MA, US

I 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.

Boston, MA, US

• GE 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.
• 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.
• 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.
• 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.
• Managed document control departments and MRP for engineering of two GE companies with annual saving of $210K.

US

• Publicly 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.
• 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.
• 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.

• Biotech 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.
• 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.

Ba, Biological Science

Bs, Mechanical Engineering

Mba, Marketing & Finance