KEITH CHRISTENSEN
KCQAengineer@gmail.com
7520 Stuart Street, Westminster, Colorado 80030
303-594-8084

PROFESSIONAL BACKGROUND

10+ years experience in Medical Devices relating to Quality and Regulatory Management with spinal and orthopedic devices. Heavy emphasis on complaint handling, CAPA’s, ISO 13485 Standards and Auditing. Experience also includes implementing and managing clean rooms from class 10 to 10,000 and plastic injection molding of medical device parts. Many years of experience with validation protocols ( IQ,PQ and OQ) and Risk Management ( ISO 14971).

	RELEVANT EXPERIENCE

Adecco Temporary Service, Lone Tree, CO                                                                  7/2011 – Present
Various Temporary positions – Metrology Technician
QC Inspector for Medical Device Plastic Parts and QA Technician.

Boulder BioMed, Boulder, CO					                    8/2010 – 3/2011
Contracted Position.
QA/Regulatory Affairs Manager
Product Manufactured: Hearing aid devices with electronic chips.

•	Responsible for managing the ISO 13485 Quality Program.
•	Responsible for managing CAPA’s, customer complaints and root cause analysis.
•	Responsible for creating and assembling the technical package for CE mark certification.
•	Provide regulatory guidance for organization.
•	Developed and wrote procedures and other documents.
•	Developed and implemented the non-conformance QSR program. 
•	Managed QSR under FDA 21 CFR parts 801 and 820.
•	Assemble and packaged product for shipment to customers.
•	Obtained international medical device license for Canada
•	Managed suppliers of device parts. 

Microlife Medical Home Solutions, Inc. Golden, CO                                                   2/2008 – 12/2009                                                   QA/Regulatory Affairs Manager
Products Manufactured: Blood Pressure Monitors, cuffs and electronic calorie meters.

•	Responsible for managing CAPA’s, customer complaints and root cause analysis.
•	Responsible for managing the ISO 13485 Quality Program.
•	Obtained ISO 13485 and CE Certification for company.
•	ISO Management Representative for company.
•	Provided regulatory guidance for staff and corporate.
•	Developed and wrote procedures and other documents.
•	Managed and trained personnel for the Internal Audit Program.
•	Reviews and approves product documentation.
•	Responsible for auditing supplier of plastic parts for our BP device.
•	Responsible for Quality Investigations to buy new equipment.
•	Developed Lean Manufacturing initiatives using Time Studies and Value Stream Mapping.

 Aorist Technical Staffing, Wheat Ridge, CO                                                                 3/2007 – 11/2007
 Contracted as Sr. Production Planner for 8 months
•	Developed BOM’s for machined parts.
•	Responsible for writing manufacturing instructions.
•	Scheduled parts for quality testing functions.

	Alpha Pro Tech, Inc., Nogales, AZ                                                                  10/2003 – 2/2007                        QA/Regulatory Affairs Manager
Products Manufactured: Dental Instruments, gowns, Surgical Masks and dental office electronic monitors.
Responsible for daily management of the Quality Department, staff of 8 personnel which
included QE’s, Quality Supervisor and inspectors.

•	Responsible for customer complaints, Corrective Action Reports and root cause analysis.
•	Responsible for Internal Audits of other facilities and suppliers.
•	Responsible for QA Systems in Mexico and China locations.
•	Responsible for all Regulatory issues with the FDA.
•	Responsible for insuring all manufacturing specifications are complied with.
•	Managed Quality System under ISO 13485, ISO 14971 Risk Management and FDA 21 CFR 
     Standards 820.
•	Responsible for managing the sterile disposable program.
•	Responsible for Medical Device design protocols and R&D from design to production.
•	Responsible for validating equipment and process’s and writing protocols.
•	Responsible for Internal Audits of the QSR System and leading Management Reviews.
•	Responsible for performing process and equipment validations.
•	Managed and audited suppliers to make sure they are conforming to our requirements.
•	Managed Quality Investigations to optimize facility usage.
•	Responsibilities included developing Lean Manuf. – 5S, Value Stream Mapping and Kaizen. 
	
Westmed, Inc., Tucson, AZ                                                                                            10/2001 – 8/2003                                                                                                                                                                                                                                                                                                                                    Quality Assurance Manager
Contracted Position
Responsible for daily management of the QC Department and compliance to FDA standards for medical
Devices, staff of 7. 
Products Manufactured: Electromechanical power generators, Wound care kits and machined orthopedic devices, foot and arm braces.
 
•	Developed sterilization processes and wrote validations for new products and equipment.
•	Used CAD KEY to design plastic disposable medical devices.
•	Developed assembly layouts and wrote procedures for new medical device products.
•	Responsible for all FDA standards being complied with in a medical device facility.
•	Managed plastic injection molding operations of adult and pediatric plastic disposable oxygen masks.
•	Responsible for the operation and standards adherence of the Clean Room.
•	Developed my own Internal Auditing course with handouts to use in training auditors.
•	Class 10,000 clean room implementation and Management.
•	Responsible for Quality Investigations to reduce scrap.

Arizona Property Savers, Phoenix, AZ                                                                             5/1992 – 9/2001
Company built new homes and office complex’s and renovated them also.
Positions held: QA Manager, Construction Site Director and Warehouse Manager.

•	 Responsible for solving customer complaints.
•	 Managed all subcontractor activities.
•	 Responsible for complying with all city and state building codes.
•	 Managed and audited suppliers of construction materials.

Honeywell Commercial Flight Systems, Phoenix AZ                                                   4/1990 - 4/1992	
	Position: Quality Engineer/Senior Manufacturing Engineer
Responsible for developing quality control and manufacturing procedures to produce PCB’s, high and low volume production runs of electromechanical assemblies, implementing and overseeing the surface mount chip and component area. Staff of 12

•	Implemented a total Lean Manufacturing (5’s, APQP, 8D’s) area to include Kanban development,   quality work teams, work cell design, assembly layout and work instruction writing.
•	Implemented an ESD Program for the manufacture of CCA's and electromechanical products.
•	Developed a supplier certification program using statistics and vendor training methods.
•	Responsible for daily management and problem solving of aerospace component assembly lines to include surface mount engineering on printed circuit boards.
•	Served as facilitator and trainer of employee Quality Teams and taught group dynamics.
•	Responsible for engineering of the SMT area, process improvements for the Wave Solder and Work Cell areas.

Neomed, Inc., Sacramento, CA                                                                                       9/1981 – 3/1990
	Position: I.E.,/Senior Quality Engineer/Manufacturing Program Manager
Products: Orthopedic devices, Spinal Implants and General Surgical Devices.
Responsible for implementing all quality controls to include TQM, SPC, DOE, and the J.I.T. Manufacturing Program and capital equipment acquisition. Staff of 35

•	Managed all manufacturing of the class 2 and 3 medical device sterile disposable product line which 
     included electrosurgical pencils, EKG Monitoring Pads, plastic injection molded multi-valve director 
     and a body suction device. 
•	Responsible for the machining and assembly operations of disposable arthroscopic knee surgical instruments and determining what sterilization process to use.
•	Managed the medical device plastic injection molding operation which included using Lexan, ABS,
PVC, PET, Acrylic, Nylon and other polycarbonates.
•	Developed and managed the medical device disposable Clean Room operation which included
     material and equipment acquisition, validations and training of personnel.
•	Implemented Lean Manufacturing process improvements on the medical device production work cell.
•	Responsible for manufacturing operations and training on injection molding, screw and CNC milling machines, and all new assembly equipment purchased.
•	Wrote all technical work instructions to include insertion of critical quality checks.
•	Managed a high volume medical device plastic injection molding production area to include equipment maintenance, production lines and new/capital equipment acquisitions.
•	A period of 4 years was spent in Research and Development of new plastic materials and medical device packaging. Also responsible for FDA Compliance and wrote 510K's.
•	Implemented the 5S’s and 8D manufacturing guidelines to save over 800K a year in manufacturing costs.
•	Responsible for device design protocols from prototype/R&D to manufacturing on production floor.
•	Responsible for Auditing of the entire QS to include documentation and storage and handling.
•	Trained on Part 1271 of the CFR.
•	Managed the QSR and compliance requirements for domestic and international drug development.
•	Spent 4 years in Pharmaceuticals with filling bottles with pills and packaging development of products.
•	Responsible for auditing pharmaceutical fill assembly operations.
•	Developed, Implemented and Managed work cell operations for pharmaceuticals.

EDUCATION/CERTIFICATIONS/PROFESSIONAL AFFILIATIONS

B.S. Industrial Engineering – Southern Illinois University, Carbondale, IL
Certified ISO 9001 Lead Auditor/Auditor
Member – ASQC
Green Belt Certification