Senior Corporate Supplier Quality Auditor Resume Wayne, NJ - Hire IT People

OBJECTIVE:

Versatile quality assurance engineer, with twelve years of proven quality, regulatory and management experience, wishing to use my skills and dedication to quality to advance within a consumer healthcare/ pharmaceutical environment

PROFESSIONAL EXPERIENCE:

Confidential, Wayne, NJ

Senior Corporate Supplier Quality Auditor

Responsibilities:

Responsible for managing 3rd Party Supplier Quality performance as per GMP requirements for Resin Compounding, Extrusion and Metal Stamping commodities within teh Medical Device Industry, in particular drug eluting stents.
Assess 3rd Party supplier GMP capabilities and compliance as per ISO, FDA, ICH guidance through direct visits, technical discussions and Quality System Audits.
Manage supplier performance, taking corrective action as needed for resolution of non conformances. Communicate quality issues to suppliers and provide assistance to develop/approve change controls, deviations, IQ/OQ/PQ, and validations.
Liase with internal manufacturing plants to address raw material and finished product quality issues. Assign CAPA’s as needed.
Lead negotiations between internal manufacturing plants and 3rd Party suppliers, establishing and maintaining positive relationships when conflict situations occur.
Develop assessment criteria for potential preferred suppliers.

Confidential, Wayne, NJ

Senior Manufacturing Engineer

Responsibilities:

Identified causes for production quality issues (scrap / waste) and utilised six sigma problem - solving skills to formulate improvement plans. Reduced production scrap by 63%.
Present strategic plans and performance reviews to Senior Management and production operators.
Introduced Lean Manufacturing best practices through site wide training.
Developed and improved manufacturing SOPs and work instructions.
Carried out change controls, root cause/ product quality investigations.
Maintained staff records of training implemented and training TEMPeffectiveness.

Confidential

Receiving Inspection Manager

Responsibilities:

Managed receiving inspection processes and personnel during a period of rapid growth (Production increased by 500%). Developed strategic plans for department to meet demands.
Directly supervised a department of four Inspection Operators.
Review and disposition non-conforming material.
Set-up component validation programs and managed new component / change control introduction.
Performed external audits for new supplier qualification and ongoing supplier surveillance.
Developed and implemented test and inspection methods for incoming materials.
Carried out root cause investigations utilising six sigma problem solving skills on supplier quality issues. Co-ordinated TEMPeffective corrective actions leading to a timely close out.
Member of teh internal Quality Audit team, auditing to ISO standards.

Supplier Quality Assurance Engineer

Confidential

Responsibilities:

Based at a strategic supplier's manufacturing site, assisted in Developing and maintaining a comprehensive system of supplier management for key US suppliers including communication methods, documentation requirements, etc.
Managed teh supplier development program in teh United States in order to continuously improve flexibility, production capability, quality and cost.
Collaborated with supplier for teh achievement of teh regulatory standards. Developed suppliers Quality Manual, SOPs and Work Instructions and Production /Quality Metrics.
Managed vendor quality rating systems.
Developed Quality Process Auditing System.
Issued and actioned on Non-Conforming Material Hold Tags.
Supported teh development, validation and introduction of new products or processes, and reviewed ongoing requirements ensuring customer requirements, needs and expectations were met. Generated and monitored PFMEA’s, Quality Control Plans
Reviewed engineering requirements and other technical information in order to assess potential manufacturing issues through prototype, pre-launch and production build stages.

Confidential

Manufacturing Engineer

Responsibilities:

Responsible for overall equipment TEMPeffectiveness for 8 high volume production lines for an automotive safety critical rated device.
Managed a production team of 2 supervisors, 73 operators and 2 quality inspectors.
Developed process documentation, i.e. Work Instructions, PFMEA, change control plans
Introduced new products by carrying out production line trials and run-at rates.
Kaizen continuous improvement activities, including scrap, 1st time through FTT, etc.
Performed a process and procedural Gap analysis on company’s process /procedures manual against North American Automotive standard, QS 9000. Addressed weak areas by investigation processes, and proposing process improvements and associated procedures introduction