Kenneth J. Maynard Jr.

** ******* ***.

Islip Terrace, NY 11752

Cell 631-***-****

Home 631-***-****

acbqro@r.postjobfree.com

COMPUTER SKILLS/ KNOWLEDGE:

Window 98, 2000, XP O/S, MS Access 2000, MS Excel, MS

PowerPoint, MS Office, MS Word.

TRAINING: ISO 13485, FDA cGMP: 21 CFR 820, 210,211; MDD

93/42/EEC Annex II, FDA QSIT, ANSI, ISO 9001, ESD

Control, 5S, Lean Manufacturing, IPC 610 Specialist

WORK EXPERIENCE:

Oct. 2013 to Present: CAPA Director

US Non Wovens Brentwood, NY 11717

Responsible for the development, maintenance, and

continuous improvement of the company’s quality

management systemin regards to Corrective and

Preventative actions.Ensure ongoing compliance to FDA

/ cGMP / BRC requirements.

Oct 2009 to Mar 2013: Quality Manager / Acting Quality Engineer

Recor Medical, Formerly ProRhythm Inc., Menlo

Park CA.

Oct. 2004 to Sept. 2009: Quality Manager / Acting Quality Engineer

ProRhythm, Ronkonkoma, NY 11779

Responsible for the management of clinical trial complaints,

investigations, and root cause analysis on all returned

product, and customer complaints reported during E.U.

and U.S. clinical trials.

Responsible for the development, maintenance, and

continuous improvement of the company’s quality

management system to ensure ongoing compliance to

ISO13485 / MDD / FDA / cGMP requirements.

Firmware validation to support current clinical trials and

products. Device verification / validation.

Assist in the development and establishment of product

specifications. Risk management.

Analyze statistical data and product specifications to

determine standards and establish quality and reliability

objectives of finished product

Track and trend vendor performance, internal non-

conformance and field complaints.

Direct the Clean Room Monitoring Program which includes

the internal microbiological sampling and monitoring of

the clean room, particulate counts, as well as

bacteriological analysis of finished products.

Reliability testing on all sterile and non sterile products used

in clinical trials.

Plan, schedule, and conduct quality audits both internally

and externally.

Document audit observations, evaluate impact, make

recommendations for corrective actions.

Implemented standard operating procedures into quality

system, follow up on effectiveness and efficiency.

Stream lined and implemented new processes to increase

efficiency and effectiveness within the QA department.

Managed and ensured CAPA/FAI/MRR/SCAR processes are

implemented and closed when required.

Management rep for notified body (BSI)

Quality management review meetings.

Supervise staff and coordinate activities within quality

department.

Safety officer, building maintenance.

Other misc. duties as assigned by Quality Director,

President.

Nov. 1999 to Sept. 2004 Incoming Quality Control / Instrument

Coordinator

Miteq Inc, Hauppauge, N.Y. 11788

Coordination of daily calibration and equipment activities,

training.

Test and Inspection of PCB, assembled, raw, surface mount,

thru-hole technology. Other various electronic

subassemblies and components.

All tasks related to the maintenance of electronic test

equipment. Scheduling of calibration and repairs. The

calibration of mechanical measurement tools. Negotiation

and purchasing of service contracts. Composed monthly

recall lists for all capital equipment. Loss prevention of all

capital equipment.

Jan 1993 to Oct. 1999 Quality Control Supervisor / Production

Coordinator /

Warehouse & Inventory Manager

SMAR Research Corp. Ronkonkoma, NY 11779

The creation of Quality Manual, S.O.P. / B.O.M. for all in

house assembly.

Responsible for quality staff.

Incoming and Final materials. source inspections, vendor

audits.

Track and trend vendor performance, internal non-

conformance results

Inspection of Printed circuit boards, raw and assembled.

Surface mount and thru-hole technology. Other various

electronic components.

Successfully implemented and managed MRP system.

Negotiated manufacturing contracts and scheduling with

contract assembly houses.

Purchasing of raw materials.

Supervised and managed all inventory and shipping

responsibilities.

Aug. 1989 to Feb. 1992 Quality Control Inspector

Grumman Space and Electronics Division, Great River

NY 11739

Responsible for the incoming inspection, solder-ability

testing, accelerated ageing, mechanical and visual

inspection of various subassemblies, printed circuit

boards, connectors and other hardware used on military

aircraft.

Non conformance reports, customer returns and other

assigned duties.

Certified category C inspector: WS-653E & Mil-S-45743

Jan. 1986 to July 1989 Quality Control Inspector

Standard Microsystems Inc., Hauppauge, NY 11788

Responsible for the Daily calibration of the clean room

measurement equipment.

Responsible for the incoming inspection of raw materials that

were to be used in the wafer fabrication facility.

Frequent interaction with management, engineering and

vendors.

Non conformance reports, customer returns and other

assigned duties.

Was loaned out to R&D for various assignments.

REFERENCE Professional and personal references furnished upon request

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