SUMMARY:

• Quality Engineer and an accomplished and astute leader wif extensive experience in quality and process improvement, customer / technical support, Six Sigma problem solving, corrective actions and CAPA investigations.
• Managed performance: Maintenance of systems to third party standards, ISO13485, (21CFR820, 210, 211), EU MDR, MDSAP, ISO9001) requirements and offered mediation of audit findings including FDA 483’s. and consent decree
• Over 20 years work experience as a Quality / Manufacturing Engineer, in a variety of manufacturing industries and offers teh ability to identify root cause and implement permanent problem closure. Dedicated to providing teh very best support to Customers, external and Internal.
• Managed staff at multiple locations, including shipping/receiving, also first piece inspection, calibration and supplier quality engineer.
• Active involvement wif new plant startups / production transfers. New facilities: 2 in Ireland. Production transfer, 1 to Germany, 1 to China and 1 wifin US.
• Supported medical device - Pharma and consumer product industries to name a few and TEMPhas over 6+ years exposure/experience wif Supplier Quality issues. Supported key suppliers during teh Implementation of Quality Agreements.
• Internal audit lead driving maintenance of QMS to ISO compliance through measurement, analyzing and review for continual improvement. Audit results are discussed during management reviews.
• Validation: developed IQ, OQ, PQ’s and executed validations. 5 years using Minitab for statistics
• NPD 10 years working on new designs and design product transfers.
• Author of many procedures and implemented PPAP's, FMEA's, Design Control, SOP's WI and CAPA’s.

PROFESSIONAL EXPERIENCE:

Confidential

Quality Engineer

Responsibilities:

• Validation of equipment move.
• Update Bills of material (BOM) wif quality requirements
• Completed BOM project in 60% of teh time allocated

Confidential, NJ

Sr. General Quality Engineer

Responsibilities:

• Risk analysis on multiple part
• Working wif suppliers in Europe and US. Supplier visit in US.

Confidential

Supplier Quality Engineer

Responsibilities:

• Reducing large backlog of Supplier change Notifications wif risk management.
• Worked on high risk notification in coordination wif Subject Matter experts for closure of teh investigation.
• Identified a better, quicker wif better clarity in completing teh risk management documents.
• Worked wif purchasing to develop a system generated excel spreadsheet to simplify process of supplier notification investigations.

Confidential

Quality Engineer

Responsibilities:

• In depth investigation of Non-Conformance reports that were CAPA based.
• Designed destructive test using fixtures and a force gauge. Sampled and collected data for engineering studies on long term, internal and Customer failures

Confidential

Validation Quality Engineer

Responsibilities:

• Validation of Lab equipment which included ovens, sterilization equipment (autoclave), cutters for lab samples.
• Updated templates for IQ, PQ for review by lab personnel GLP. Added calibration of instruments to teh IQ and reviewed safety wif engineering during teh IQ review.
• Reviewed IQ findings and forward upon satisfactory results to lab personnel for review. PQ determined samples and testing wif teh lab team and recorded results in teh PQ template. Monitored sample testing and recorded results via Minitab and process for final signoff to teh Team.

Confidential

Quality Engineer Supervisor

Responsibilities:

• Responsible for Return Goods Department to confirm if return was valid, warranty return, etc.: Three Direct reports.
• Floor and supplier trouble shooting and MRB disposition of rejected material.
• New product Development team member.
• Internal auditor for system upgrade to MD SAP standards.

Confidential

Lead Validation Quality Engineer

Responsibilities:

• Validation of used equipment transferred from a different out of state facility, existing facility equipment due for revalidation or was never validated previously and new equipment purchased.
• Total number of validations, 27 used and existing equipment. 6 new pieces of equipment.
• Equipment included laser etchers, a grinder, EDM equipment, CNC lathes and machine centers, autoclaves and an oven. Also included was a multi cleaning process. IQ, OQ was performed on existing equipment and for new IQ, OQ, PQ were applicable.
• Worked wif customers on type of data for statistical requirements for validations and design control.
• Investigate cause of failed validation to include equipment, fixtures’ and measurement technique.
• Trainer of operators on teh importance of sampling for statistical analysis and problem solving. For me to be successful they have to be successful.

Confidential

Quality Engineer

Responsibilities:

• Generate and review DHR records which included GCP, cGMP before submission to teh Customer.
• Disposition Non-conforming material. Disposition after investigation to rework, wrote detailed steps to include quality auditing and Risk Assessment.
• Internal Auditor for QMS compliance.

Confidential, Highland Heights, OH

Lead Supplier Quality Engineer

Responsibilities:

• AnalyzeNon-conforming significant material backlog and disposition of material through investigation which included ECR changes from time of rejection and risk management.
• Recommended changes to teh NCM process to improve notification of NCM to suppliers.

Confidential

Supplier Quality Engineer

Responsibilities:

• Remediation of 100+ suppliers SCAR’sthrough Risk Assessment and cGMP at 4USDePuy Syntheslocations and one in Switzerland where me was on site.
• Created detailed flow chart and WI for decision levels for risk management.

Confidential

Lead Supplier Quality Engineer

Responsibilities:

• Audit multiple molding suppliers’ company assets (end of life project). Review Preventive Maintenance agreements and tool conditions.
• Arranged for corporate tooling engineer for support in resolving tooling issues and ensure tooling requests from teh supplier were processed in a timely manner.
• Mentored a company quality engineer on quality issues to resolve on going molding quality issues at suppliers.
• Successfully had critical suppliers committed to Supplier Quality Agreements

Confidential

Engineer

Responsibilities:

• Improvements to work instruction to accurately record assembly of complex equipment.
• Write and executeIQ, Validations on existing production ovens.
• Identified root cause of long term defect that was design related.

Confidential

Corporate Quality Engineer

Responsibilities:

• Gather and analyze Customer complaints for trends in product failure category.
• Final review of CAPA’s for multiple sites for customer returns
• Investigated and successfullyresolved a long term quality issuesby improving teh design of an electrical mechanical pump frequently serviced part that is teh company’s responsibility. Cost savings in excess of $100k per year which included two product lines.
• Site leader (Lake regional Medical/ Viant Medical: Wheeling IL Jul2015) for a Six Sigma team that identified teh top 18 high volume scrapped components and teh team reduced scrap cost significantly by 54% wifin teh target completion of 8 weeks.
• Continued to monitor daily reject levels via gap analysis using tools like SWOT to disposition suspect material on teh production floor.
• Recognized for outstanding customer (Laird: Schaumburg IL Mar 2013) support for gage R&R and capability studies for inspection vision system approval. dis project was for a multiple compartment, tight tolerance part before a big contract was ed.
• Identified failures for fragile components in packing wif design control and FMEA’s. Created a work instruction for teh design of packaging that significantly reduced rejects.