Quality Control Manager
Resume:
Kenneth J. Maynard Jr.
Islip Terrace, NY 11752
Cell 631-***-****
Home 631-***-****
***********@*****.***
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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