Contract, Quality Positions Resume

SUMMARY:

Quality Engineering and Quality Management professional with medical device and automotive safety critical component experience has successfully developed and upgraded quality management systems, achieved audit readiness, reduced defect rates, validated manufacturing processes, designed and validated measurement systems, improved customer satisfaction, increased product throughput, and lowered total cost of production.

PROFESSIONAL EXPERIENCE

Contract, Quality Positions

Confidential

Responsibilities:

Cook Medical, Bloomington, INQuality Engineer
Philips Medical, Andover, MAQuality Management System Engineer
Smiths Medical, Gary, INSenior Lead Validation Engineer
Confidential Biomet, Trauma Div., Warsaw, IN Senior Supplier Quality Engineer
Atrium Medical, Hudson, NHTEMPPrincipal Quality Engineer
DePuy Synthes, Monument, COManufacturing QE, Risk Management
Performed ISO Audit Readiness and FDA Investigation Readiness
Evaluated Supplier Monitoring Process for QSR compliance and effectiveness
Supported Australian Therapeutic Goods Administration (TGA) investigation
Created Master Validation Plans (MVP)
Implemented Design Input and Design Output tracking system
Performed and evaluated process capability studies including Pp and Ppk indices
Determined and documented product acceptance criteria and inspection techniques
Performed Supplier Production Process Acceptance (SPPA) for sourced product
Provided guidance and coached suppliers in areas of deficiency or uncertainty
Assisted suppliers in their drafting of process validation protocols
Reviewed and approved supplier process validations including IQ, OQ, and PQ
Facilitated Test Method Validations (TMV) and Measurement System Analysis (MSA)
Reviewed concepts through product design and development phases to ensure ability to be efficiently manufactured and effectively measured
As part of Design Transfer Process, reviewed and approved Process Control Plans and Measurement Systems
Trained and advised Quality Engineers on validation concepts, requirements, and techniques
Remediated Design History Files (DHF) as part of Corrective and Preventive Action (CAPA)
Evaluated and improved component and assembly prints and specifications
Updated Design Failure Mode Effect and Criticality Analysis (DFMECA) records
Performed design review to assure product manufacturability
Remediated risk management documentation in compliance with ISO 14971:2012

Confidential, Warsaw, IN

Senior Engineer II, Quality

Responsibilities:

Assisted in making improvements to Measurement Instruction Sheets (MIS) and work instructions which provided 72% reduction in documentation errors as measured at Device History Record (DHR) final review
Rationalized and reduced inspection required within profit center by 35 % overall and by up to 67% on specific product lines
As Lead Quality Engineer, supported manufacturing of hip stems in eight (8) profit centers with 158 production associates
Performed Quality Investigations and submitted Quality Investigation Reports (QIR) on time while achieving 100% CAPA review committee acceptance rate
Facilitated development and execution of Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) per 21 CFR 820.75
Member of Validation Core Teams for nitride, diffusion bond, high - energy plasma spray (HA/TCP), laser cutting, and final clean processes
Quality Subject Mater Expert (SME) supporting heat-treat processes in three (3) profit centers
Participated in internal quality system audit to verify compliance with 21 CFR Part 820 and ISO 13485 per ISO 19011
Trained and certified production operators on the use of measurement equipment, interpretation of drawing requirements, Good Documentation Practices (GDP), and requirements of Standard Operating Procedures (SOP)
Created and maintained Quality Operating System (QOS) charts posted within production departments
Reviewed production drawings for proper application of tolerances (per ASME Y14.5M) and ability of product to be measured

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