Scott Lolmaugh

**** *. ******** ******, ****, AZ 85204, United States

Mobile: 949-***-****, acyahl@r.postjobfree.com (www.linkedin.com/in/scottlolmaugh)

SUMMARY OF QUALIFICATIONS

10+ years’ experience in QA as manager, engineer, and auditor; directing regulatory, risk management, process validation, document control, testing and inspection activities in highly regulated industries.

10+ years’ Certification as Six Sigma Black Belt demonstrates a thorough understanding of statistical problem solving methodologies and lean techniques with the ability to perform investigations, initiate and lead improvement projects, analyze and resolve quality problems.

10+ years’ experience in new product and process development with advanced microelectronics and electromechanical assembly and manufacturing, including soldering, SMT and semiconductor fabrication in a high-reliability environment.

Expert in multiple assembly and manufacturing processes; able to audit, qualify, and approve new or existing suppliers in multiple technologies and industries.

PMI PMP Certified, License 1821407

10+ years’ experience developing, maintaining, improving, supporting, and auditing ISO quality management systems including, ISO 9001, ISO 13485, and AS9100.

MBA with emphasis on Global Management.

Ability to develop, maintain, track, trend and report SMART metrics associated with programs and projects.

Strong computer skills and proficiency, including MS Office applications (Word, Excel, PowerPoint, Project), Minitab statistical software, and many others.

Excellent communicator, presenter, trainer, and team facilitator.

Demonstrated self-starter who works well in either a team environment or as an independent contributor.

Strong people-skills including collaboration, facilitation, active listening, creative problem solving, and excellent attention to detail without micromanaging.

EDUCATION & CERTIFICATIONS

Project Management Professional 2015

PMI #: 1821407, Expires: June 2018

Masters, Business Administration - Global Management, Minor: Global Management 2009

University of Phoenix, Phoenix, AZ, GPA: 4.0

ISO 9001 / ISO 13485 Quality Management System Auditor 2004

Exemplar Global, Milwaukee, WI, Certification # 103798, Expires: Nov 29, 2017

Six Sigma Black Belt 2000

Six Sigma Qualtec, Tempe, AZ

Bachelor of Science, Industrial Engineering, Minor: Business

Eastern Michigan University, Ypsilanti, MI

EXPERIENCE

Sr. Quality Engineer, Sustaining Engineering (Temp)

CR Bard, Tempe, AZ (Temp)

2015 to present

Responsible to support Supplier Management & Development.

Track, maintain, and drive timely closure of SCARs.

Credentialed Supplier and Internal auditor.

Developed a robust and risk-based SCAR procedure with multiple levels of action output.

Quality Manager

HEI Inc., Tempe, AZ (Company Closed)

2014 to 2014

Quality Manager (Mgt. Representative) for high-reliability flex and rigid-flex circuit board manufacturing, responsible for:

AS9100 Quality Management System (1 Auditor), Document/Change Control (1 Technician), NCs, CAPAs (1 Engineer)

Inspection, Product Acceptance (6 Inspectors), Electrical Test (2 Operators), Regulatory, including AS9100, ISO 9001, ITAR

Primarily responsible to develop, maintain, analyze, report, and act on effective Quality Metrics.

Senior Manager Quality Assurance

Ulthera Inc, Mesa, AZ

2012 to 2014

Managed and facilitated the Quality Assurance (QA) organization with responsibilities including ISO 13485 and ISO 14971 Risk Management compliance, Quality Management System (QMS), Document Control, Control of Nonconformances, CAPAs, Supplier Management, Internal and Supplier Auditing.

Developed and updated metrics within the QMS to provide meaningful feedback to stakeholders.

Completely updated Risk Management procedures including establishing FMEA procedure and forms to more fully comply with ISO 14971 requirements.

Senior Design Quality Engineer

Cardiac Science, Laguna Hills, CA

2010 to 2012

Provided QA input to new product design process and facilitated design transfer to manufacturing. (E,g,: "DFx" - Design For [Manufacturing/Testability/Reparability/Serviceability/Etc.])

Led and documented nonconformance investigations and corrective and preventive actions (CAPA) efforts to demonstrate effective corrections are made.

Led and supported product complaint investigations. Ensured that conclusions from investigations were appropriately supported by facts, assured that CAPAs addressed root cause, and all aspects of the investigations were thoroughly documented.

Led and supported efforts to complete Health Hazard Evaluations to ensure timeliness, accuracy of the information, and complete documentation.

Led and supported risk assessment activities using quality tools such as FMEAs, Hazard Analysis and Process Flow Maps.

Provided QA input and approval for requirements, test protocols, and other controlled documents.

Senior Supplier Quality Engineer

Masimo, Irvine, CA

2009 to 2010

Managed supplier quality for over 100 suppliers with a focus on PCBAs, PCBs, Capital Equipment, Molded Plastic Parts, Packaging, Labeling, Tapes, Adhesives, and Sterilization Services Providers.

Managed supplier qualification and approval and performed supplier audits around the world.

Dispositioned nonconforming material reports and supplier corrective actions associated with suppliers.

Interfaced with customers and supplied feedback and corrective actions as required to support customer satisfaction.

Supported the QMS and third party audits to maintain certifications and regulatory requirements.

Developed a balanced scorecard system for annual evaluation and continuous improvement of critical suppliers. This system provides a quick-view summary of a supplier on six fronts; including: Technology, Quality, Responsiveness, Delivery, Cost, and Global Citizenship.

Principal Quality Engineer

Emulex, Costa Mesa, CA

2007 to 2009

Managed supplier quality of Electronics Manufacturing Services providers domestically and internationally; issued, tracked and managed supplier corrective actions; coached suppliers in six sigma, 8D and 5S methods for improvement.

Provided in-house as well as on-site supplier ISO 9001 auditing.

Managed customer quality concerns; managed process change notifications to customers.

Provided QA input for new program development teams including manufacturing validation and process qualification process.

Principal Quality Engineer

Cameron Health, San Clemente, CA

2004 to 2007

Set up and managed receiving Inspection, equipment calibration activities, and inspectors to establish the function.

Managed suppliers and performed supplier audits to comply with ISO 9001 or other applicable QMS’.

Performed audits for compliance to ISO 13485 and FDA QSR to cGMP for class 3 implantable medical electronic devices and accessories. RABQSA Certified Auditor.

Trained to ISO 14971:2000 standard for Risk Management to apply risk assessment to the QMS.

Developed process and system verifications and validations, including packaging, sterilization, SMT, cleaning, and soldering.

Utilized Six Sigma Black Belt techniques to define, monitor, analyze, improve, and control all internal processes.

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