Professional Profile

Distinguished highly empowered professional offering a successful career with over two decades of professional excellence predominantly in the areas of operational excellence, quality management, and technical support in Aerospace and Industrial regulated industries. In-depth exposure to regulatory affairs, compliance, auditing, quality assurance, quality control, auditing & assessments, CAPA, Risk Analysis, R&D, mergers & acquisitions, in high-growth, rapid change environments. Established performance benchmarks in directing/managing complex manufacturing and compliance operations. Up-to-date knowledge of recent amendments in the standards and regulations stated by the authorities for ISO, AS, AIAG, CSA, GOST-R, INMETRO, IEC, NEC, and ATEX. Creative, innovative, results-driven with immaculate work habits, excellent personnel management, and leadership skills.

Objective

Currently looking for a senior leadership career opportunity that will provide a challenging avenue to significantly contribute to the efficiency, organization, growth, and profitability, and will make best use of existing skills and experience gained whilst enabling further personal and professional development ideally as Head of Quality Management, in a regulatory affairs management role.

Performance Milestones

Created a quality and process oriented culture across 32 plants in a global organization to create a baseline for achieving certification to ISO, ATEX, AS, AIAG, INMETRO, GOST-R for FAA, IEC, IEC Ex and NEC industries

Hold the distinction of successfully leading regulatory and internally identified non-compliance remediation efforts including CAPA letters

Strategically initiated programs and alliances to transition culture from reactive and corrective to predictive and preventive

Deftly identified and led continuous improvement opportunities in non-conforming materials, processes, MRB and complaints, supplier qualification and manufacturing first-pass yield; and implemented statistical techniques including trend analysis

Judiciously created supplier risk-based evaluation programs, quality plans, established metrics, inspection plans, and modified as necessary to reduce, more fully characterize products and allow flexibility for modification with increased process knowledge

Raised quality management systems and operations to peak performance levels through creative, hands-on leadership

Career Summary

EATON Corporation, Crouse-Hinds Division, Syracuse, NY 8/1996 – 10/2019

Successfully hosted across 32 plant registration inspections and all other agency inspections, and customer & partner audits

Earned significant corporate exposure and relationship development as Global Compliance Liaison

Credited for initiating management and annual review processes to ensure identification and timely resolution of improvement opportunities including use of risk analysis, pFMEA

Competently performed as regulatory liaison and Global ISO Management Representative; successfully negotiated compromises in compliance setting

Adroitly led project to evaluate competencies and deploy general and job-specific training curricula

Compensated for having efficient execution and validated results of work assignments

Proactively contributed, while collaborating with senior staff, to develop Hoshin Plan, including, corporate breakthrough strategy, key strategies and initiatives, performance metrics and oversight of deployment; led/participated in regular progress reviews

Eminence of being one of the six senior staff gate keepers required for determining and approving Go-Stop-Hold project status. Authorized product innovation and product line extension roadmaps and project plan according to a Stage Gate process

Dexterously perform technical assessments and gap analysis and supply regulatory guidance to clients in compliance with ISO, AS, AIAG expectations for quality systems, compliance programs, and master corporate plans

Accredited for hosting successful Explosion proof equipment, ISO, ATEX, INMETRO, GOST-R, site inspections as well approved products and facility inspections by UL, FM, CSA, Intertek, DEKRA, and Baseefa

Set stringent quality standards and ensured strict adherence with no occasions of compromise

Drove initiative in quality assurance domains, including all fine aspects covering qualifications & validations, quality audits, documentation, in-process quality assurance and special process & instrumental gauge analysis and records management

Recognized as a strong advocate of compliance, a good trainer and leader, and an accomplished manager of technical resources with a proven record in building and motivating successful QA efforts

Pioneer in development and approval of ISO qualification and validation protocols, basic automated control systems, process, and analytical methods

Assume initial and interim site and corporate responsibility for quality operations and compliance

Instrumental in interdepartmental and intercompany negotiations, including directing and coordinating activities of validation registration contractors, staff management and resource planning to meet customer timelines and control cost

Gear the activities for the development and implementation of the core quality system for operations start-up of manufacturing sites including CAPA systems

Distinction of providing consulting services to 25 certified assembly manufacturers located in US and Canada

Direct and coordinate all assessment activities of third-party registration contractors

8/2015-10/2019 Eaton Corporate Global Certification and Compliance, Sr. Manager, EATON Corporation, Syracuse, NY

Shouldered the responsibility for compliance certification within 32 plants residing in 26 countries

Assessed requirements across all functional areas and periodically reviewed performance by deft application of concurrent corporate audit procedures aligned to certification and standards

Efficiently liaised with registration Compliance Officers and successfully presented quality system structure of policies, procedures, processes, and records management

Propagated Quality Policy and Quality Counsel movement and developed quality culture in the work force to achieve quality leadership in the industrial explosion-proof and commercial fittings industries

Collaboratively worked with operations and quality at all levels of the organization to ensure that; all standards, regulatory and statutory requirements were met, processes operate in a state of control and compliance and continuous improvement is a top priority within their area of control

Regularly ensured dependable and timely results from quality control, including process control and support for process changes in compliance with ISO requirements

Accomplished the responsibility to develop site process and procedures for deploying corporate policies; developed efficient archival programs in addition to managing budgets and personnel

Accountable for leading multi-site corporation wide team for change control process standardization; acted as a team-member and site liaison for a corporation wide complaints handling and CAPA standardization team

Provided regulatory guidance to ensure all post-marketing activities associated with the company's production were in compliance with FDA's regulations and guidance

Interacted with the senior management, team, and associates to facilitate smooth communication to understand and analyze the requirement and also to identify appropriate solutions for problems

3/2009-8/2015 Division Quality Assurance Manager, EATON Crouse-Hinds, Syracuse, NY

Drove the efforts to prepare for hosting, facilitating and closing out internal and external inspections/audits and coordinated the response and corrective actions to observations

Expertly managed resource planning to meet timelines and control costs and play interim staff roles in quality and technical services

Ensured that all projects and validations were in compliance with and AS9100, TS16949, ISO9001, ISO80079-34, and ATEX Directive, as plant applicable

Judiciously participated in third party submission packages

Meticulously monitored product quality reviews, management reviews and preparation of quality reports

Identified shortfalls in awareness/understanding/access of process and practice while providing effective solutions; handled incident and non-conformance reporting

Established Corporate Quality Training program for all new internal auditors

Facilitated the plant integration, for mergers and acquisitions and product transfer and information exchange with recipient sites as a key quality management team member

Spearheaded the product review and release, document control, compliance and training teams

1/2005-8/2009 Manager Quality Assurance, Standards and Regulatory Affairs, EATON Crouse-Hinds, Syracuse, NY

Scrupulously planned and led efforts to improve overall compliance and resolve time critical regulatory challenges for explosion proof, and intrinsically safe electronics products including electrical junction boxes, molded products, and commercial fittings.

Reviewed existing systems & procedures and designed internal controls/quality audit checks for various operational areas for achieving higher operational efficiency, resource rationalization and cost reduction

Actively involved in preparation of the product development report, master formula card, process optimization protocol and stability protocol

8/1996 – 1/2015 Manager and Supervisor Roles in Quality Assurance, EATON Crouse-Hinds, Syracuse, NY

Various quality and compliance development roles planned and led efforts to improve overall compliance and resolve time critical regulatory challenges for explosion proof, and intrinsically safe electronics products including stainless boxes, switch rack, and assembly operations

9/1991-8/1996 Quality Assurance Supervisor/Radar & Sonar Systems, Lockheed Martin, Syracuse, NY

Education & Certifications

M.A. Policy Studies, State University of New York, Empire State, Albany, NY

o Master’s Thesis: A Study of ISO9001 And The Lasting Effects on Business

B.A. Chemistry and Biology, State University of New York at Oswego, Oswego, NY

British Standards Institute (BSI) Certificate: ISO9001:2015 Lead Auditor

British Standards Institute (BSI) Certificate: Quality Management Systems

Certifications Master Certificate Six Sigma Black Belt, Lean Six Sigma – Eaton Corporation

Eaton Corporation - Malcolm Baldridge Examiner

Project Management (PMP)

Skills

SAP

PROPM – Clarity

Ms Office Suite

Language - English

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