OBJECTIVE:

• To help businesses excel and achieve World - Class status using my extensive quality assurance, consulting, facilitation and experience.

SUMMARY:

• Aerospace and Automotive Quality Assurance QS 9000 Experience - Experience includes developing and managing quality program requirements for Cessna Aircraft Engine Monitoring System to comply with AS9100 and ISO 9001 quality management system requirements.
• Extensive professional experience in development of QS/ISO 9001 compliant quality management systems
• Directed over 12 companies to ISO 9000
• Developed & implemented internal audit programs
• Extensive course experience - internal auditing 3-days, quality system awareness,
• SPC, root cause analysis, cost of quality & document development & control
• Extensive facilitation experience with cross functional groups

PROFESSIONAL EXPERIENCE:

Confidential, Westborough, MA

Lead Supplier Quality Engineer

Responsibilities:

• Perform Supplier Assessments
• Qualify Suppliers
• Support NPI Projects
• Initiate and Manage SCAR’s
• Perform Supplier
• Prepare and Present Monthly and Quarterly Metrics

Confidential, Raynham, MA

CAPA & Internal Audit

Responsibilities:

• Manage CAPA Process
• Act as Mentor and Coach for CAPA & Audit Program
• CRB Chairperson
• Maintain and Report CAPA & Audit Program Metrics
• Manage Internal Audit Program

Confidential, Waltham, MA

CAPA Remediation Engineer- Contractor

Responsibilities:

• Determine RCA
• Implement Solutions
• Perform VOE activities

Confidential, Braintree, MA

Supplier Quality Engineer

Responsibilities:

• Core duties and responsibilities:
• Perform supplier assessments
• CAPA/SCAR Follow-up
• Supplier Risk Assessments per ISO 14971
• Supplier Performance Assessment

Confidential, Marlborough, MA

Quality Systems Manager

Responsibilities:

• Manage 6 person team consisting of 3 functions (Calibration, Supplier & Software QA) in support of Research & Development activities:
• Responsibilities include:
• Resource Planning, Hiring, Budgeting, Performance Reviews, Metrics Preparation
• Provide project direction, coaching and mentoring for quality engineering and regulatory compliance to technical team, consisting of a Supervisor, Sr. Supplier and Software QAE’s
• Realized $17000.00 in department cost savings/avoidance via VIP-Value Improvement Initiatives
• Lead implementation of process improvement and CAPA systems
• Responsible for timely preparation and reporting of monthly and quarterly metrics
• Review of metrics for associated trends, for possible escalation to senior management
• Over-sight of Software Validation Activities associated with the Quality System and Test Equipment
• Over-sight of Supplier QA activities: Onsite & Desktop Audits, supplier addition and removal from AVL
• Supported the Confidential Internal & External Audit Programs

Confidential, Norwood, MA

Sr. Quality Assurance Engineer

Responsibilities:

• Provide QAE support to Sensor & Hardware Manufacturing Lines
• Core duties include: MRB activities, supplier audits, operational performance metrics, process capability studies
• Create & Approve ECO’s using Agile
• Documentation of Risk Assessments
• Create & Track Nonconformance’s
• Perform Trend Analysis
• Supervise 3 person Quality Control Department

Confidential, Indianapolis, IN

CQT Engineer/Consultant

Responsibilities:

• Participate as member of CAPA remediation team
• Perform Stryker CAPA Gap Assessments
• Review CAPA’s for compliance with company 4D Problem Solving Process & Procedures
• Identify gaps and create CAPA Gap Reports
• Schedule meetings with CAPA owners and SME’s and present findings to team
• Initiate and manage CAPA remediation efforts to secure CAPA closure

Confidential, Plymouth, MA

Quality Systems Manager

Responsibilities:

• Responsible for all quality and regulatory matters
• Re-mapped all Level II processes to comply with ISO 13485 & 9001 QMS standards
• Primary interface with ISO 9001 & 13485 Registrar, customer audits and the FDA
• Responsible for internal audit program course development & delivery
• Responsible for management and execution of internal and external QMS audits
• Manager a 5 person Quality Control staff
• Manage Root Cause & Corrective Action 8D System
• Plan and manage the internal Audit program
• Developed SPC, IQA and Gage R&R courses

Confidential, Portsmouth, RI

Sr. Performance Excellence Engineer

Responsibilities:

• Perform Internal Assessments, including AS9100, CMMI and Contract Compliance
• Identify opportunities for improvement
• Record assessment results in catsWeb and Internal Quality System Assessment databases

Confidential, Norwood, MA

Quality Assurance Manager

Responsibilities:

• Created company quality culture via extensive efforts in a fast growing start-up
• Set-up entire QA system to include supplier management, calibration,, tracking of nonconformance’s, corrective actions & ECO’s & manufacturing process controls
• Set up both internal and external document control systems
• Researched and implemented electronic document management system
• Coordinated company-wide in use of this system
• Designed & implemented internal quality audit program
• Trained and mentored 10 person internal audit staff
• Developed FAA (CFR 14, Part 21) & AS9100/ISO 9001 compliant quality management system documentation
• Developed defect and cause codes to facilitate trend analysis for corrective action program
• Implemented SPC program (Gage R&R & Cpk studies & pareto analysis)
• System Reliability tracking and predictions (MTTR, MTTF, FMECA)
• Developed supplier rating and quarterly report card system
• Review complex aerospace and aviation contracts for pertinent quality requirements
• Ensure quality system addresses varying OEM quality requirements
• Designed and set-up company-wide system (52 person company)
• Company point of contact for all regulatory (FAA) matters

Confidential, San Ramon, CA

Project Director-Quality Management Consulting

Responsibilities:

• Provide leadership and direction to client companies including facilitation, document development, and management consulting services for the purpose of achieving Management System to QS/ISO 9001.

Confidential, Hoboken, NJ

Management Systems Lead Auditor

Responsibilities:

• Planned, managed, directed and performed ISO 9000 Management System Audits of client companies. Assumed Lead Auditor role for Westinghouse, Georgia Pacific, AT&T, Lucent Technology, Bell Laboratories, York International & Dresser Rand

Confidential, Canton, MA

Quality Control Supervisor/Engineer

Responsibilities:

• Supervised 3 Quality Control Technicians, prepared proposals and administered military & commercial contracts
• Performed work flow analysis and process capability studies utilizing Design of Experiment (DOE), CpK, Gage Repeatability and Reproducibility studies

Confidential, Braintree, MA

Quality Assurance Engineer

Responsibilities:

• Developed Military Quality Assurance/Control Programs compliant with MIL-Q-9858, MIL-STD-1520, MIL-I-45208 & MIL-C-45662
• Facilitated concurrent engineering activities leading to successful transition from FSED to FSD
• Participated in MRB & CCB activities
• Prepared Inspection Checklists
• Responsible for review and approval of ECN’s, Work Instructions and Configuration Management Plans
• Assisted with the development of supplier partnership programs
• Performed supplier evaluations