SUMMARY

A senior/principal level Quality Engineer with a background in Biotechnology and Medical Device industries whose responsibilities included product evaluations, quality assurance, corrective/preventative action plans, product investigations and validations and risk analysis and mitigation while working in a team environment and delivering results in a timely manner. Strong verbal and written communication skills. Proficient in Microsoft Office Suite, Minitab, FMEA, validation and qualification methodologies, product testing methods and FMEA risk analysis methodologies.

NON-TECHNICAL WORK EXPERIENCE

September 2022 – Current

FedEx Ground, St. Paul, MN, Package Handler

●Responsible for working with teammates using safe lifting techniques to load various sized packages into transport trailers ensuring items are undamaged and safe for unloading

●Maintain safety of work area ensuring packages are loaded in a timely manner

●Work with management to improve conditions with goal in mind to streamline package handling

TECHNICAL WORK EXPERIENCE

August 2021 – August 2022

Actalent (Aerotek) Staffing / Teleflex, Inc., Maple Grove, MN, Contract Quality Engineer

●PFMEA risk analysis and remediation for product transfer of four product lines to Tecate Mexico

●Spearhead implementation of new test method including authoring TMV’s, test procedures, training personnel, conducting gage R&R’s, analyzing data and reporting of results

●Support OQ/PQ activities for receiving facility as an approver

●Conduct IQ activities for implementation of test procedure and product transfer

●Act as internal supplier quality rep for transfer supporting establishment of bill of material items and QMS documentation

●Resolved investigations of non-conforming components and raw materials at receiving facility

●Ensured compliance to company required training

June 2019 – August 2021

Actalent (Aerotek) Staffing / Medtronic, Inc. Plymouth, MN, Contract Quality Engineer

●Standardize quality documentation review according to cGMP requirements through generation of standard templates and procedure alignment

●Root cause analysis and risk assessment resulting in effective and timely resolution of issue

●Execution of design qualification protocols through QA lab analysis and data analysis using Minitab

●PQ report generation and approval to support customer schedule requirements

●First Article Inspection (FAI) of new process fixturing for implementation into manufacturing process

December 2018 – April 2019

SSI Staffing / Philips Healthcare, Maple Grove, MN, Contract Quality Engineer

●Perform DFMEA/UFMEA/PFMEA risk analysis remediation for product acquisition

●Spearhead deliverable completion by recruiting cross functional representatives providing leadership and guidance

February 2018 – December 2018

Real Lifesciences / Medtronic, Inc., Brooklyn Park, MN, Contract Quality Engineer

●Perform DFMEA/PFMEA risk analysis for product transfer

●Spearhead deliverable completion by leading cross functional representatives to achieve schedule milestones

●Review and approve change orders

●Conduct root cause and corrective action investigations addressing manufacturing non-conformances

September 2017 – February 2018

Real Lifesciences / Phillips Medisize, Hudson, WI, Contract Quality Engineer

●Standardize quality cGMP documentation through generation of standard templates and procedure alignment

●Non-conformance root cause analysis and risk assessment resulting in effective and timely resolutions

●Execution of PQ level design qualification protocols including data acquisition through QA lab analysis and data analysis using Minitab 18

●PQ report generation and approval supporting customer schedule requirements

●First Article Inspection (FAI) of new process fixturing to implement in manufacturing process

June 2017 - September 2017

Aerotek Staffing / Smartrac - Linxens (RFID), Chanhassen, MN, Contract Quality Engineer

●Coordinate final visual and quality inspections of final product

●Reduced/eliminated product defects and improved process and product through root cause / corrective action activities

●Reduced production down time by improving equipment PM

●Reclaimed approximately 30% product on MRB into production

●Perform test method validation of production instrumentation ensuring measurement and monitoring capabilities

●Calibration coordinator for vendor onsite calibrations

●Ensure ISO standards compliance of manufacturing process through gap analysis

April 2016 - April 2017

TE Connectivity - Creganna Medical, Plymouth, MN, Contract Quality Engineer

●Recovered $50,000+ of finances in returned supplier material

●Facilitated supplier product optimization resulting in 10% process yield gains

●Evaluate and disposition non-conforming product

●Qualify new suppliers for cost saving initiatives

●Cross functional team lead for risk analysis (PFMEA) and R&D process optimization

●Develop and implement final QA inspection procedures

●Statistical data analysis using Minitab and MS Excel (distribution analysis, descriptive statistics, ANOVA, capability analysis, etc.)

February 2013 - July 2015

Greatbatch Medical, Plymouth, MN, Senior Quality Engineer

●Disposition non-conforming product

●Improve product and process through root cause corrective action analysis

●Reduce down-time through root cause and corrective actions that assured non-recurrence of cause

●Performed test method validations for qualification of process monitoring

●Participate in cross functional teams for risk analysis, process development and process monitoring implementation

●Review and disposition IQ, OQ, PQ and PFMEA quality documentation

March 2012 - February 2013

Wipro Technologies / Medtronic Inc., Minneapolis, MN, Contract Quality Engineer

●Conduct IQ, OQ, PQ activities for transfer efforts

●Led cross functional team to generate equipment specification procedure and template

April 2006 – March 2012

Medtronic, Inc., Minneapolis, MN, Senior Quality Engineer

●Led cross-functional teams to successfully complete PFMEA risk analysis, gage R&R and DOE for process optimization, and root cause investigations

●Generate / execute protocols for existing and new manufacturing processes

●Coordinate with test lab to initiate and prioritize test requests for analysis

●Statistical data analysis and reporting of lab data protocol results

●Assist Regulatory to prepare 510 (k) and PMA submissions

●Quality Core Team member for delivery systems and manufacturing transfer projects

●Evaluate and disposition non-conforming released product

●Provide quality support for transition of Manufacturing Execution System (MES) to FACTORYworks

●Provide quality support for sterilization qualifications / validations

●Conduct root cause corrective action activities to support CAPA investigations

2002 – 2006, Abbott Bioresearch Center, Worcester, MA, Validation Engineer

●Generate and execute IQ, OQ and PQ protocols for existing and new process equipment, cleaning and sterilization validations, and temperature-mapping studies on process equipment and environmental chambers

●Coordinate and manage validation activities with production and plant support

●Establish user requirements for Laboratory Information Management System (LIMS)

●Review and report protocol results

●Generate and update SOPs for equipment replacement and non-conformity investigations

PROFESSIONAL TRAINING / CONTINUING EDUCATION

●On the job training in medical device qualification and validation of product and manufacturing processes

●On the job training in qualification and validation of Biomedical equipment and manufacturing processes

●EMT Basic

●OSHA Confined Space Rescue Training, 29 CFR 1910.146

●Engineer Intern, State of Colorado

ASSOCIATIONS / HONORS

●Medtronic Corporate Star of Excellence

●ChemDesign Employee Recognition Award

●Bayer Presidential Achievement Award

●Runner-up Bayer Presidential Achievement Award

EDUCATION

Colorado School of Mines, Golden, Co.

●Bachelor of Science, Chemical Engineering, 3.0

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