Engineer Quality

DOUGLAS RUPERT

SUMMARY:

. Engineering Professional with >10 years of strong experience in Quality

Engineering, Quality Assurance & Control, Validation, Manufactuing in

Medical Devices, Contract Manufacturing & Aerospace industries.

. Assured compliance to ISO 9001:2008, 21 CFR Parts 201, 802, 806, 820,

ISO 13485, IO 14971, the EU Medical Device Directives (MDD) and the

Canadian Medical Device Regulations (CMDR).

. Managed CAPA, SCAR, NCR, CPAR, NCMR and Internal Audit systems and

processes, ensuring compliance with established internal, corporate, and

regulatory requirements.

. Used DMAIC and Process Control strategies to resolve manufacturing

defects for continuous improvement; Reduced manufacturing defects by an

average of 12% per year using Continuous Improvement methodologies; with

the use of control charts, maintained 6 Sigma on multiple Military

Aerospace programs with many jobs having a tolerance(s) in the .0002"

range, with plating.

. Wrote validation protocols (IQ, OQ, PQ) and reports for all software and

hardware product changes; revised & updated all procedures, work

instructions and forms, including the Quality Manual.

. Participated in the Risk Management, Recall and Post-Market Surveillance

(PMS) processes, as required to ensure compliance with established

internal, corporate, and regulatory requirements.

. Maintained calibration and inspection equipment program; expert in use of

measuring devices, including calipers, micrometers, calibrated loops,

scales and height gauge.

. Implemented 5s strategies for all facets of the production floor to

minimize unnecessary movement of staff with the purpose of increased

productivity.

. Implemented quality strategies for all facets of the production floor to

minimize rejects and maximize productivity.

EXPERTISE:

. GD&T, ANSI Y14.5M-1994.

. Trained and Certified in Total Quality Management System (TQMS).

. Six Sigma Green Belt Cerfication and Black Belt Training.

. AS9100, U.S. QSRs, ISO 13485 and ISO 9001.

. Excellent computer skills including E2, Outlook, Solidworks, Draft Sight,

Adobe Illustrator, Microsoft Word, Excel, Powerpoint and Office.

Extensive NDT training, usage and experimentation, including, CMM, Zyglo

(Magnaflux), Std. Laue (Back reflection x-ray), visual inspection,

microscope, Xray, HiPot, ground resistance and ultrasonic.

EDUCATION:

. BS, Major Mechanical Engineering Technology West Coast University, Los

Angeles, CA, 1989

. Green Belt Certification, Black Belt Training.

. Total Quality Management System training and certification.

. Qualified Internal Auditor and trainer for Internal audits.

. 200 hours of training in scheduling, problem solving and continuous

improvement at Mc Donnel Douglas.

. Cad Training in Solidworks and Autocad Mechanical Desktop.

. Licensed California Metal Contractor #927111, own a part time metal

fabrication business, Ironworx.

. Worked as crew on American LeMans car racing team.

EXPERIENCE:

Machinetek LLC, Carlsbad, CA Jun 2014 - Present

Quality Manager/Production Manager

AS9100, SO 9001, Boeing 5317

. Maintain the Production schedule and assure that all tasked priorities

are being accomplished on time.

. Works in partnership with production teams to deliver parts on time that

meet the acceptance criteria.

. Revamped the A9100 system to assure compliance, including revision

control of all documents, Mylars, drawings.

. Implemented a contract review process that addresses all specifications,

qualifications and requirements at all tiers.

. Use DMAIC and Process Control strategies to resolve manufacturing defects

for continuous improvement.

. Accomplish hardware and software Risk Analysis and Design Control

programs as required.

. Manage the CAPA, SCAR, NCR, CPAR, NCMR and Internal Audit systems and

processes, ensuring compliance with established internal, corporate, and

regulatory requirements.

. Incident/Defect Management, Classifies, prioritizes and coordinates

remediation of defects, Identifies patterns of incidents.

. Initiated steps to comply to NADCAP, Boeing 5317 and Boeing DPD.

. Write validation protocols(IQ, OQ, PQ) and reports for all software and

hardware product changes.

. Maintain calibration and inspection equipment program.

. Revise and update all procedures, work instructions and forms, including

the Quality Manual.

. Chair MRB activities.

KAP Medical, Corona, CA 2012 - 2014

Quality Manager

ISO 9001, ISO 13485

. Maintain the Production schedule and assure that all tasked priorities

are being accomplished on time.

. Reduced manufacturing defects by 48% in 2012-2014 using lean

manufacturing techniques.

. Reduced Quality Control manpower costs by 50% in 2012-2013 through

productivity increases.

. Implemented 5s strategies for all facets of the production floor to

minimize unnecessary movement of staff with the purpose of increased

productivity.

. Use DMAIC and Process Control strategies to resolve manufacturing defects

for continuous improvement.

. Accomplish hardware and software Risk Analysis and Design Control

programs as required.

. Write validation protocols (IQ, OQ, PQ) and reports for all software and

hardware product changes.

. Manage the CAPA, SCAR, NCR, CPAR, NCMR and Internal Audit systems and

processes, ensuring compliance with established internal, corporate, and

regulatory requirements.

. Assure compliance to ISO 9001:2008, 21 CFR Parts 201, 802, 806, 820, ISO

13485, IO 14971, the EU Medical Device Directives (MDD) and the Canadian

Medical Device Regulations (CMDR).

. Maintain calibration and inspection equipment program.

. Revise and update all procedures, work instructions and forms, including

the Quality Manual.

. Train Internal Auditors and oversee the successful completion and

reporting of Internal Audits.

. Responsible for the collection and reporting of metrics and data to

management.

SPF Machining, Irvine, CA 1995 - 2011

Senior Quality Engineer

ISO 9001, AS9100

. Reduced manufacturing defects by an average of 12% per year using

Continuous Improvement methodologies.

. With the use of control charts, maintained 6 Sigma on multiple Military

Aerospace programs with many jobs having a tolerance(s) in the .0002"

range, with plating.

. Trained machinists on the use of control charts to control dimensions

with a very high degree of success.

. Developed a method to better maintain the maintenance of the 25 CNC

machines being used.

. Controlled the Asset list, calibration system and tooling Logs.

. Implemented quality strategies for all facets of the production floor to

minimize rejects and maximize productivity.

. Member of Material Review Board (MRB).

. Built a system to pre-stage jobs in the computer and on the floor to

eliminate shortages and increase productivity.

. Maintained CAPA and NCMR system.

. Participated in the Risk Management, Recall and Post-Market Surveillance

(PMS) processes, as required to ensure compliance with established

internal, corporate, and regulatory requirements.

. Introduced, created and monitored Control Charts for all critical

machining operations.

. Represented QA to support development projects, as necessary, ensuring

proper design control practices are utilized.

. Reviewed and approved engineering changes and design control changes.

. Responsible for the collection and reporting of metrics and data to

management.

Mc Donnell Douglas Corporation, Long Beach, CA 1987 - 1995

Senior Engineer / Scientist Specialist

. Continually evaluate and improve manufacturing and engineering processes

and procedures in support of MD-80 and MD-11 programs using TQMS, Kaizen,

Six Sigma and Lean Manufacturing Principles.

. Track and trend part shortages and deviations in products and processes.

. Worked with suppliers on improving part deliveries such as barrel

sections from Convair, San Diego and related schedules.

. Promoted to Lead Engineer in support of MD-11 Airworthiness design

approval for European delivered aircraft.

. Lead Engineer on MD-11 Quality Assurance team.

. Lead Engineer on Airworthiness MD-11

. Federal (FAA) and international (JAA) regulatory experience.

. Worked as FDA liaison on MD-11 program.

. 200 hours of training in scheduling, problem solving and continuous

improvement.

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