Quality Assurance Manager Resume Cranbury, NJ - Hire IT People

SUMMARY

Quality Management professional with experience in Quality Engineering and Regulatory Compliance for Pharmaceutical, Medical Device, Automotive, and Aerospace products industry.
Strengths include combining technical writing skills with business expertise to streamline processes while complying with domestic and international requirements.
Results - oriented, consistently delivering high quality outcomes and recognized for ability to develop strong and productive partnerships with customers.

TECHNICAL SKILLS

Six Sigma Green Belt, Lean Manufacturing, ASQ, CQE, SAP, IPC-610 & 7711, KANBAN, Microsoft Office, Form Tool, SPC Minitab.
Global Food Safety Initiative (GFSI) standards (i.e. AIB, BRC, SQF, USDA, HACCP).
CNC, CMM, TQM, ASME, FMEA, FTA, OSHA, HACCP, FDA, FAA, GD&T, GMP, PPAP, (21 CFR § 110, 210, 211, 820, 29 CFR § 1910).
Quality Systems, Project Planning, Gap Analysis, Root Cause Analysis, CAPA, Measures of Performance and Effectiveness, Objectives Matrix Improvement Techniques, Review Test Method Validation, Protocols, Process Method Validations, Batch Record Reviews, Injection Molding Set-Up, and Inspection for Engineering Design Approvals.

PROFESSIONAL EXPERIENCE

Confidential - Cranbury, NJ

Quality Assurance Manager

Responsibilities:

Responsible for quality assurance functions across all shifts in support of production operations.
In partnership with operation management, lead process for continuous improvement of customer satisfaction and compliance. Initiate, review or approve documentation including MPI, SOP, Work Instructions, Quarantines, Investigations, Deviations, Protocols, Complaints, CAPA, Change Controls, and Training records.
Participate in regulatory agency and customer audits. Maintain required regulatory documentation.
Lead internal / external audits and perform supplier audits. Develop and maintain internal audit program.
Lead development of project specific quality procedures and documents in coordination with customers and internal personnel.
Developed and drove improvements in quality and business systems and processes. Reduced company processes by 37% resulting in first year cost savings of $187K and second year cost savings of $82K due to continuous process improvements.

Confidential - Logan Township, NJ

Quality Assurance Manager

Responsibilities:

Responsible for managing two Quality Engineers and four Quality Inspectors with technical oversight and evaluation of products, parts, PPAP, operational and quality processes.
Analysis and disposition of non-conforming materials including determination of root cause and generation of corrective action plans utilizing statistical process evaluation techniques.
Collected, compiled, and reported data on Cost of Quality and appropriate Key Business Metrics.
Proactively acted on results and provided solutions for corrective action or continual improvement of Quality Management System throughout operations.
Internal Corrective Actions, CAPA, MRB, Supplier Corrective Actions and Customer Quality Issues (QDRs) utilizing skills around Six Sigma analytical principles.
Supported in-house vendor source approval, certification, and completion of efficient program for vendor Quality Assurance through vendor contacts and audits.
Quality improvement through design and drawing review, improvement of inspection and quality control procedures, and evaluation and measurement of operations processes to reduce Non-Quality Costs.
Advised Director of Quality Assurance on planning, staffing, strategies and budgets.
Provided guidance on quality and Lean culture and expectations to Quality Assurance Technicians, Inspectors, and operations.

Confidential - Berlin, NJ

Sr. Quality Assurance Engineer / Manager

Responsibilities:

Managed four Quality Engineers and six Quality Inspectors on two shifts.
Built and updated QSR and MDD - compliant system for R&D and operations.
Site liaison for domestic and international compliance activities including internal and supplier auditing, corrective / preventative actions, and complaints.
Participated in NPD teams, providing input and guidance on areas of quality and design control, Software, corrective / preventative actions, CAPA.
Performed statistical analysis, wrote technical reports and provided support in resolution of product complaints, product problems or safety issues.
Led site certification to Medical Device Directive (MDD) Annex II, ISO 9001, EN46001, and ISO 13485 through BSI. Attained level of credibility with BSI resulting in audit time reduction of 50%.