• Exceptional leadership in a global, matrix organization managing the Quality, PMO, Continuous Improvement / Operational Excellence, Metrics, Engineering, Continuous Improvement and PMO organizations of the company.• ITAR/EAR Compliance Officer• Developed a comprehensive global quality management system, resulting in a significant reduction in product defects and customer complaints.• Designed and executed a strategic NPI Phase Gate process with Smartsheet dashboards to enhance product design and engineering processes at all sites, resulting in improved product transfer performance and increased customer satisfaction.• Implemented an operations dashboard reporting structure, chairing successful site monthly KPI reviews, resulting in streamlined production processes, reduced waste, and improved productivity.• Led cross-functional teams in the successful launch of new product transfers, ensuring adherence to quality standards, timelines, and cost objectives.• Successfully managed and resolved complex technical issues globally, collaborating with internal teams and customers to identify root causes and implement effective corrective actions.• Engineered, trained and successfully rolled out a risk based CAPA, Complaints and Non-conforming process with Smartsheet log monitoring.• Improved the Internal Audit program by streamlining audit checklist and reporting forms, including the implementation of a global audit lessons learned Smartsheet log for collaboration and trending of gaps and best practices among sites. • Implemented a robust supplier quality program, including supplier audits and monthly risk, capacity and scorecard performance evaluations, leading to improved supplier performance and reduced supply chain risks.• Played a key role in driving continuous improvement initiatives by developing and implementing a cost reduction SmartSheet tracker, fostering a culture of quality and innovation throughout the organization for each site

Consult for companies over various industries in QMS system development, classroom training and quality certification.• Updated ISO 13485:2016 Lead Auditor qualifications and exam as member of Exemplar Global medical device board.• Contracted to help companies transition to ISO 13485:2016, ISO 9001:2015 and AS9100D standards.• Updated ETI Group ISO 13485:2016 Internal Auditor curriculum.• Assisted companies in QMS development, successfully completing ISO certification.• Work with Aerospace companies in audit prep and system conformance to AS9100 and AS9110.• Senior Lead Consultant for SQA Services, Quality Auditing and ETI Group, performing contract work for medical device, aerospace and automotive companies through supplier audits, training and QMS management.• Experience in auditing compliance to ISO 13485:2016, 21 CFR Parts 801, 803, 806, 807, 820, 830, MDD 93/42/EEC, MDSAP and TG(MD)R.

• Responsible for quality at all Celestica Industrial programs worldwide with focus on Monterrey, Romania and Ireland sites• Executive quality approval on all segment NPI Phase Gate design reviews • Mentor site quality leaders in all aspects of quality including customer 8D and CAPA approvals for RCCA analysis• Supplier Management regarding new supplier qualification and product change validation• Alignment of QMS procedures and processes through site gap assessment and corrections

Global project and site responsibilities/accomplishmentsCorporate quality leader for key customer program • Retained key customer after development and completion of recovery plan affecting business at three main global Celestica sites• Led improved process controls and KPIs to highest result since beginning of program, reducing rework and retesting costs• Successful completion of all customer and regulatory qualification audits with on time actions, closure of previously failed audits and passing scores since start of managing quality segment for troubled customer program • Completion of Lean Six Sigma Black Belt training with project scheduled for completion in 2020Celestica Portland site support• Prepped and supported site for successful FDA inspection• Led customer qualification audits successfully winning new business• Maintained regulatory compliance/training and led site in ISO 13485 and ISO 9001 re-certification audits

• Managed team of 27 employees worldwide responsible for all quality activities: compliance with cGMP, review, assessment and disposition of product, CAPA, validation, change controls, customer complaints, internal audits and service activities.• Mentored and developed team promoting several staff members to departmental supervisors and instituting cross functional training and succession planning policies• Maintained ISO 13485, ISO 9001 and FDA registration at the site as responsible Management Representative to FDA and regulatory bodies• Updated quality management system to medical device/FDA standards with the successful transition to ISO 13485:2016 and ISO 9001:2015 recertification. An estimated cost savings of $60,000 in lieu of hiring a consultant and foregoing Stage 1 registration.• Monitor Lean tools on floor for continuous improvement quality activities.• Identified and created Key Performance Indicators Quality Dashboard at site, driving Quality Culture and Efficiency.• Led site to highest customer quality scores in recent years. • Performed Internal Auditor Training and assisted multiple sister Celestica sites for successful ISO Certifications.• Supplier Quality Management through on-site audits, quality metric reviews and product change validations.

Design and manufacture of high precision automated solutions.• Created Quality Management System compliant to ISO 9001:2015.• Developed and managed new Quality, Engineering Technician and Manufacturing Engineering groups.• Implemented SharePoint quality document system. • Designed quality metric issue tracking process.

Accountable for quality and regulatory compliance, hosting all site audits and management of product qualification. Quality approval in negotiation of new medical device contracts.• Managed FDA annual Regulatory Laser reporting and REACH/RoHS compliance.• Quality reviewer and approver of customer contracts for 510(k)/PMA products. • Led site to 1st time ISO 9001:2008 certification within 1st 4 months of employment.• Managed international team for the certification project, delivering on challenging time frame with limited resources.• Developed and completed transition plan for full GE quality system integration at new acquisition site, with emphasis on ISO13485 medical device certification.• Implemented new Supplier Quality / Management and validation processes at site. GEHC certified trainer for Evaluation, Investigation and Root Cause company CAPA process. Certified GEHC Lead Auditor, managing the internal auditing process at the site.

Direct Quality department for inspections of cargo hook equipment, including NDT, CMM and GD&T techniques. Evaluate and resolve issues that result from customer, Aerospace or FAA audits. Design and implement work and loss prevention to increase manpower performance and decrease costs. Successful completion of GD&T course and ISO9001:2008/AS9100C/AS9110 Lead Auditor Cert. Updated FAI process and led efforts in building new FAI database. Lead company through customer audits, including Sikorsky, Eurocopter and Boeing. Maintained Boeing Supplier Gold Performance Standard.

Completely rewrote quality management system, including the conversion and streamlining of over 400 ISO 9001 documents to obtain first time plant certification of ISO 13485, through process mapping sessions. Directed Quality Assurance department while implementing and maintaining all Quality programs to ensure compliance to customer, industry and FDA CFR Part 820 requirements. Oversaw all Auditing necessary to maintain Quality Management System. Reviewed and negotiated quality requirements of new products with customers. Facilitated Root Cause and Corrective Action programs. Coordinated customer return activities. Regulated and directed supplier quality program through audits and incoming inspection.

Manager of Quality and Safety operations at union facility with 50 million in sales. Accountable for incident safety investigations and follow up. Implemented Behavioral Based Safety and DuPont’s Take Two programs. Frequent travel to company plants and customers, including Canada and Mexico. Managed customer complaints through root cause analysis and corrective action. Responsible for 1st, 2nd and 3rd party plant audits. Prepared plant for successful ISO 9001 recertification first 3 months with company. Led plant to highest P&G supplier audit score in North America.

Assisted Quality Manager (Owner) on ISO 9001 certification. Directed lab technicians’ quality of work and equipment integrity, providing customer service support. Assured product conformity to specification. Worked with production personnel on process improvements. Provided technical support to sales team with product advice and on site customer trial experience. Played major role in research and development of new starch products, facilitating upscale from experimental to production.

Supervised 16 employees under QS 9000 quality system. Managed lab tech operation of ICP-MS, IC, HPLC, Particle Size Analyzer, DSC, and wet chemistry tests. Implemented SPC program in the Propellant Manufacturing Department. Developed Work Instructions, Procedures and addressed Customer Concerns. Monitored for continual process improvement and chaired MRB (Material Review Board). Contributed to plant record 1.8 million hours (810 days) without a lost time accident.