Quality Assurance Engineer

KIMLINH HARRIS, CQE, CQA

www.linkedin.com/in/kimlinhharris

949-***-**** • *************@*****.***

QUALIFICATIONS

Extensive experience in Medical Device Engineering with solid track record in Quality Assurance / Product Development. Experienced in initiating and maintaining Quality Management Systems, Internal and External Audits, Complaint Handling, developing Design Control phases and creating and managing design history file. Accomplished in product and process development, utilizing quality engineering skills for testing and optimizing class 1, 2 and 3 medical devices. Effectively manages multiple tasks concurrently, adapting easily to new projects, teams, systems, tools and production methodologies. Solutions-focused and hands-on project team leader, aggressively tackling every task with a positive attitude and sense of urgency; consistently able to deliver products of optimal quality, on time and on budget. CORE COMPETENCIES

Internal Audits / Supplier Audits Quality Management System / Compliance

Product / Process Validations (IQ, OQ, PQ) cGMP/QSR (FDA Medical Device Regulation)

Statistical Process Control (SPC) / Sampling Plan ISO 13485/14971/10993, MDD (MDR) 93/42/EEC

Product Stability Studies / Process Improvement Design Control/Design History File EXPERIENCE & ACCOMPLISHMENTS

HT SOLUTIONS, INC. (Class I, II & III Medical Devices) 2008-Present Director of Quality Assurance / Product Development Engineer Consultant Clients: Vestagen Protective Technologies, DermaSensor, Captiva Spine, Glaukos Corporation, Neomend, Vascular Pathways

• Transitioning Quality Management Systems of non-compliant startups into fully operational regulation- compliant companies in readiness for market launch

• Create, develop and manage Quality Management Systems 21 CFR Part 820 QSR and ISO 13485/MDD/CDMD in the following areas: supply chain quality management, NCR, CAPA and customer’s Complaint investigation and corrective actions

• Develop and conduct internal audits, supplier audits, QA inspections, risk management and design control.

• Create, develop and manage all phases of design control, design history file, statistical techniques and templates for validation protocols and reports to support existing and new product clearance/approval.

• Plan, coordinate, and execute all activities relating to development, application, and maintenance of quality processes and standards for product development and manufacturing processes, materials, and products. GLAUKOS CORPORATION, Laguna Hills, CA (Class II & III Medical Devices) 2008-2015 Product Development/ Quality Support Engineer Consultant

• Initiated, conducted, and generated reports for supplier and internal audits.

• Worked with suppliers to ensure Glaukos products, processes met specifications and projected timelines

• Initiated and conducted risk management activities such as preliminary risk hazard analysis, (D&P) FMEAs, IQ/OQ/PQ

• Conducted and assisted in developing sampling procedures and statistical process control methods, generate reports of data collected in a statistical analysis format.

• Interfaced with Operations for nonconforming material disposition.

• Created technical documents such as validation protocols/reports, test procedures/reports to support quality, manufacturing and engineering functions.

• Supported and assisted Regulatory Affairs in matters of system compliance and system audits.

• Managed the design control processes of new and existing products, developed specifications and testing methods for the clinical feasibility study products in the US and worldwide. GLAUKOS CORPORATION, Laguna Hills, CA (Class II & III Medical Devices) 2005-2007 Sr. Product Development / R&D Engineer

• Conducted and supported Research & Development projects and activities.

• Initiated and maintained the working relationship with Mayo Clinic to transfer the techniques and testing methods from Mayo Clinic to Glaukos Corporation.

• Initiated and directly worked with Orange County, San Diego and Florida Eye & Tissue Banks.

• Created and executed validation protocols/reports (IQ/OQ/PQ) for products and processes.

• Created/executed validation protocols/reports for Glaukos current products and processes under development.

• Worked with suppliers to ensure Glaukos products, processes met specifications and projected timelines

• Responsible for calibration/maintenance of R&D, clean room and production equipment and facility to ensure Glaukos complied with cGMP and FDA regulations.

INTERNATIONAL DESIGN CONTROL, CA 2001-2004

Quality Engineer / Product Development Consultant

• Developed and implemented quality systems for start up Medical Device Manufacturers to achieve FDA registration, ISO certification and CE marking.

• Planed, coordinated, and executed activities concerned with development, application, and maintenance of quality processes and standards for product development and manufacturing processes, materials, and products. MEDTRONIC / AVE, Santa Rosa, CA (Class III Medical Devices) 1996-1999 Senior Quality Assurance Engineer

• Developed and implemented quality systems to achieve FDA registration, ISO certification and CE marking.

• Assured product specifications conformance, developed statistically sound sampling systems and coordinated domestic and international quality problem resolution.

• Revised and improved quality documentation to evaluate product functionality and quality on an ongoing basis.

• Evaluated, procured and installed equipment to measure product performance.

• Hired, trained and reviewed QA manufacturing support staff.

• Performed validation plan and processes for packaging. ALLERGAN MEDICAL OPTICS, Irvine, CA (Class II & III Medical Devices) 1991-1995 Surgical Adjuncts Engineer, VIBC Group (Viscoelastics, Irrigating, Blades, Cannulas)

• Designed and developed QC laboratory, established aseptic process technology and transferred processes from Allergan in CA, USA facility to Allergan Botox/Vitrax Ireland facility.

• Developed and established clean room environments to include class 100, 1000, 10000 equipment, packaging process set-up.

• Perfomed stability studies, generated test protocols/reports, batch records and SOPs, conducted operational and performance qualifications for manufacturing equipment.

• Assured compliance to cGMP, FDA and ISO9000 guidelines for U.S. and European facilities. EDUCATION AND CREDENTIALS

Bachelor of Science in Mechanical Engineering, CSULB 2005 Master of Quality Assurance Engineer, CSUDH (in-progress) Expected 2020 BSI Certified Lead Auditor (ISO 13485:2016) March 2018 Exemplar Global Certified Lead Auditor (ISO 13485:2016) April 2018 ASQ Certified Quality Engineer, CQE Since 2011

ASQ Certified Quality Auditor, CQA Since 2012

Geometric Dimensioning & Tolerancing (ASME - Y14.5:2009) 2015 Minitab 17 Essentials & Reliability 2015

Minitab 17 Statistical Tools for Process Validation 2014 Certified Graphical Measurement Software (SmartScope/Measure-X) 2011 Member of American Society for Quality (ASQ, section 0701) 2010

Contact this candidate