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Click here or scroll down to respond to this candidate Name: Candidate's Name
Location: Kenosha WI. Street Address
Available for Interview: Street Address hours NoticeAvailable to Start: 1 weeks Notice.Education/ Certification: B.S in Industrial Education and Technology from Western Illinois University from Macomb, IL, Street Address
Six Sigma Green Belt Training from Villanova University September 2013 ISO 13485:2003 Lead Auditor Training from CALISO March 2014Quality Management Experience:Has over 30+ years of experience in Quality Assurance, Product Testing, Research & Development, Manufacturing Engineering, Manufacturing Management, Production Operations and Program Management for companies within defence, aerospace, medical device, metals, and railroad industries. Extensive background in testing and validation of new products as well as manufacturing process such as forming, stamping, welding, machining, assembly; ISO9000/9001, ISO 14971 & ISO 13485 implementation; 21 CFR Parts 803, 806, and 820. Continuous Improvement; TPM; SPC; GMP; DFMEA; PFMEA; MIL-STD; PPAP, DOE; Gage R & R s; CAPA s, IEC 60601 and Lean Manufacturing. Has strong customer and supplier experience and skills in test and reliability, start-up of manufacturing processes, quality departments, cost-of-quality, data analysis, new product design, problem resolution and procedures.
EU MDR/ MDR experience:Has experience working with European Medical Device Directive (93/42/EEC) and European Medical Device Regulation (EUMDR) 2017/745, Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169. Was working at identifying and comparing the new EU MDR requirements to the old EU MDD requirements related to notified bodies, including contracts, conformity assessment activities, audits, and obligations for the manufacturer.Supplier Quality Experience:
Has over 30 years of Supplier Quality Management experience and have been instrumental in driving quality for assigned suppliers, including quality plan implementation. Select suppliers through the company s qualification processes. Owned supplier results, drove improvements utilizing supplier scorecards, supplier audits, ensuring compliance, and driving improvement plans where needed. In-depth understanding of key business drivers; using this understanding to accomplish supplier excellence. In-depth understanding of how to work with company with other teams and contributes to the area of supplier quality. Lead on technical projects and process improvement initiatives. Focused expertise in all phases manufacturing and qualification. Responsible for both Supplier Quality Assurance and Supplier Quality Development, including supplier qualifications, action plans, audits, performance monitoring (PPAP), and assisting key suppliers towards industrial standards of excellence. Work with internal and external stakeholders to drive increased quality standards. Requires strong communication skills while partnering with stakeholders both internally and externally. Resolve issues in situations that require good knowledge and judgment within established procedures using quality engineering methodology like root cause investigation and part qualification.Project Management Experience:
Has over 30 years of Project Management experience and have been a Project Manager with responsibilities for planning, directing, and coordinating activities on designated jobs to ensure that goals and/or objectives of the job are accomplished within the prescribed time frame and funding parameters. Establishes detailed reporting to management on risk assessment, project status, and milestone completion. Combines info from QA leads, technical leads, and business analysts into ideas. Fosters help to manage dependencies among cross-product teams. Foster the team focus on the on-time delivery of agreed products. Works in partnership with the Product Owner/Product Manager to turn the product roadmap into executable projects. Closely cooperating and communicates with stakeholders, technical team members, developers, and designers. Drives project planning. Executes deployment scheduling in coordination with Dev Ops, tech lead, and Product Owner. Indicates project with reliable ticket workflows and boards. Creates schedules and milestones, manages project scope and timelines, and be instrumental to classify, identify, and manage risk for functional improvement requests. Develops and schedules projects - as per the Project Roadmap defined by the Business Owner. Proficiency using commonly accepted scheduling and project management tools. Ability to understand and communicate technical concepts to both technical and non-technical colleagues.Skills: ISO9000/9001, ISO 14971 & ISO 1348 21 CFR Parts 803, 806, and 820 TPM, SPC, GMP, DFMEA, PFMEA MIL-STD, DOE, Gage R & R s, CAPA EU MDR IEC-60601 ISO 14971 Risk ManagementProfessional Experience:Generac Power System Inc., Eagle WISr Quality Engineering Specialist III (Contract) May 2024 June -2024As the Sr Quality Engineering Specialist, I work with suppliers and personnel to improve quality systems and performance by: Promoted a continuous improvement environment by providing leadership and direction for facility teams. Guided Generac sourcing, purchasing and corporate quality personnel with the establishment of supplier expectations and objectives. Lead the resolution of supplier quality issues. Directed the overall execution of internal product audits and nonconformance resolution. lead problem solving at the plant and supplier levels. Support Production Part Approval Process (PPAP). Managed the qualification of new parts through the APQP process. Coordinated supplier quality, rework and scrap data acquisition to feed Cost of Quality Metrics. Conducted and managed audits/assessments of processes and quality systems (ISO, internal audits, etc.). Gather and analyze product data and use the data to lead improvement initiatives to reduce the potential for defects. Provided direction and assistance to the Quality Leads for prioritizing inspection tasks. Develop and modify inspection sampling plans based on supplier performance. Assisted with the identification and traceability of products. Ensured test/inspection integrity (MSA / GR&R). Acted as SAP Super User within functional area as assigned.Intech Medical. Kenosha WI Jan 2022 Oct 2023Sr. Design Quality Assurance Engineer/Sr Risk Management Engineer Support of EU-MDR submissions, FDA 510k and monitor with the team all R&D activities surrounding EU-MDR submission and 510k of manufacturing premium quality devices for the orthopedics industry. Analyze problems in design, process, and test development. Independently write technical Files, Risk Assessment, General Safety and Performance Requirements (GSPR), State of Art, IFU, Intended Use Statement and Medical Device classification.
Effectively communicate and document experimental results and related statistical analysis. Perform and document risk assessments to capture existing process knowledge and to identify gaps. Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals. Responsible for the development of Protocols and Reports with input from the Engineering Team required for Engineering Testing, Human Factors Engineering, and Design Verification (IQ,OQ & PQ s). Demonstrated ability to execute Design Verification testing, including building samples, adherence to test protocols/test methods, responsible data collection/preparation practices, and good lab practices.Tecomet, Inc., Warsaw IN. Sept 2021 Dec 2021Contract NPI Quality Engineer / Sr Risk Management Engineer Determined inspection methods/instructions and incorporate them into manufacturing process. Developed Control Plans Developed inspection criteria. Developed Risk Management p-FMEA S. Assisted with Special Process Validation. Revalidating the lines in Laser, Cleaning, and Passivation. Designed in-process gauging to be used by manufacturing and inspection groups. Consulted with Process Manufacturing Engineers (PME) in resolving quality-related issues. Worked with Tecomet s Customers on Quality matters. Performed Follow-up on external corrective action responses.Employment Gap: Looking for new job opportunities May 2021 Sept 2021Philips Respironics, Monroeville PA Dec 2018 - Apr 2021Contract Quality Design Engineer / Sr Risk Management Engineer As a contract design quality engineer, was advising Philips Respironics with the optimal interpretation of the new European MDR & IVD Regulations, which will become applicable respectively in 2020 & 2022. Working with different Philips s action teams in describing the rationale for the Philips strategy for compliance. These actions were being used as input by the stakeholders to design Philips Quality documentation.
The main goal was for the interpretive documents to remain valid for the time of the EU MDR compliance project and then be replaced after the EU MDR date of application by relevant Philips s documentation.
Was also working at outlining the technical documentation requirements of the EU MDR to provide a high-level comparison between technical documentation requirements from the present EU MDD vs the new EU MDR.
Producing templates from the EU MDR Annex II Technical Documentation for the Philips Health Systems Medical Devices product portfolio, and instructions on how to use them. Was working at identifying and comparing the new EU MDR requirements to the old EU MDD requirements related to notified bodies, including contracts, conformity assessment activities, audits, and obligations for the manufacturer and authorized representative to inform the notified body of certain incidents for Philips.
Provided functional input during development project planning to accurately assess resource and scheduling considerations.
Partnered with Product Development and other cross-functional team members to define design input (i.e., Customer, System, Hardware, and Software Requirements).
Review and approve design input and design output documentation. Partner with Product Development, other cross-functional team members and consultants/external test houses to define design verification and validation testing.
Assisted in the execution of dry runs and in oversight of official V&V testing. Review and approve verification and validation test plans and test reports. Represented quality assurance as the lead quality assurance team member in design review and phase review meetings.
Drove project/system level risk management deliverables (i.e., plans, Device Hazard Analyses, reports, and Risk Management). Reviewed and approve other cross-functionally developed risk management deliverables (i.e., ISO-14971 Risk Management uFMEA, pFMEA, IEC-60601 Requirements).
Reviewed and assess all proposed changes (i.e., Change Requests, Special Rework Instructions) to ensure proper level of testing supports implementation. Verified development project documentation was following Company procedures.Boston Scientific, Maple Grove MN / Sr Risk Management Engineer Jan 2020 Apr 2020
Contract Senior Quality Engineer (remote) As a contract senior quality engineer, I was advising Boston Scientific with the optimal interpretation of the new European MDR & IVD Regulations, which will become applicable respectively in 2020 & 2022. I was working with different Boston Scientific action teams in describing the rationale for the Boston Scientific strategy for compliance.
These actions were being used as input by the stakeholders to design Boston Scientific Quality documentation. The main goal was for the interpretive documents to remain valid for the time of the EU MDR compliance project and then be replaced after the EU MDR date of application by relevant Boston Scientific documentation.
Was also working at outlining the technical documentation requirements of the EU MDR to provide a high-level comparison between technical documentation requirements from the present EU MDD vs the new EU MDR.
Producing templates from the EU MDR Annex II Technical Documentation for the Boston Scientific Medical Devices product portfolio, and instructions on how to use them. I was also working at identifying and comparing the new EU MDR requirements to the old EU MDD requirements related to notified bodies, including contracts, conformity assessment activities, audits, and obligations for the manufacturer and authorized representative to inform the notified body of certain incidents for Boston Scientific.
Provided functional input during development project planning to accurately assess resource and scheduling considerations.
Partnered with Product Development and other cross-functional team members to define design input (i.e., Customer, System, Hardware, IEC-60601 Requirements and Software Requirements).
Review and approve design input and design output documentation. Partner with Product Development, other cross-functional team members and consultants/external test houses to define design verification and validation testing.
Assisted in the execution of dry runs and in oversight of official V&V testing. Review and approve verification and validation test plans and test reports. Represented quality assurance as the lead quality assurance team member in design review and phase review meetings. Drove project/system level risk management deliverables (i.e., plans, Device Hazard Analyses, reports, and Risk Management). Reviewed and approve other cross-functionally developed risk management deliverables (i.e., uFMEA, pFMEA).
Reviewed and assess all proposed changes (i.e., Change Requests, Special Rework Instructions) to ensure proper level of testing supports implementation. Verified development project documentation was following Company procedures.Vesta Inc., Franklin WI Aug 2018 - Oct 2018Contract Senior Quality Engineer
As a contract Senior Quality Engineer, I was responsible for ensuring Vesta s Purchase Specifications for supplier s match the customer specific requirements are covered as well as any additional requirements Vesta may have to ensure product quality.
The Purchase Specifications will be sent to the suppliers of the product for their review and agreement.
Once the supplier agrees, the Purchase Specifications are then approved and implemented at Vesta. The incoming product and documentation will be reviewed against the updated Purchase Specifications.Employment Gap: Jan 2018 Jul 2018 Had a surgery so took some time off.Zimmer-Biomet Surgical, Dover OH Aug 2016 - Dec 2017
Contract Senior Quality Engineer
As a contract Senior Quality Engineer, I was responsible for reviewing closed CAPA s, Manage CAPA Work Stream, CAPA investigations, CAPA & compliance audit trending of quality data streams. Develop & establish continuously improving plans for site CAPA system, quality assurance programs & quality policies.
Plan, schedule & execute internal quality audits program for ventilation design sites. Lead a team of auditor(s) to perform audits / assessments by collecting and analysing objective evidence regarding issues and risks.
Report findings (verbally and written) to management. Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management, as appropriate.
Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.
Develop and maintain compliance policies supporting the Respiratory and Monitoring quality system. Lead process improvement projects and conduct training with Quality to improve the GBUs overall quality system compliance.
Assist with site regulatory compliance specific needs such as external audit preparation, assessment of quality plans, responses to internal and external audit observations.
Maintain working knowledge of existing and proposed domestic and international medical device regulations and guidance documents and their impact on Zimmer Biomet Surgical operations.
Prepare management reports depicting trends and useful data for management review purposes.
Support management during external inspections and participate in the management of external inspections as required.
Terumo Cardiovascular Systems, Ann Arbor MI Oct 2015 - Mar 2016Contract Operations/ Validation Engineer
As a contract Operations/Validations Engineer, was responsible for reviewing Manufacturing Work Instructions (MWI), Test Method Validations (TMV), PFMEA, PVAM, and any other documents that went along with the manufacturing process. Was validating machines, laser welding, passivation cleaning and electropolishing. After testing the process and making any red line correction, would author a Technical Report (TR) for Terumo s upper management to sign. Once the TR had been approved, would write an Engineering Change Order (ECO) to update or add missing instructions to the process documents.Terumo Cardiovascular Systems, Ann Arbor MI June 2014 - Oct 2015Contract Supplier Quality Engineer
As a contract Supplier Quality Engineer, was responsible for working between Terumo and their suppliers, by providing guidance on product and component quality requirements; generating accurate and timely supplier quality data, trends, metrics, and related reports; and determining and monitoring the effectiveness of corrective and preventive actions to resolve non-conforming issues.
In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.Primus Medical LLC, Boardman OH Feb 2013 - June 2014Quality Manager
As Quality Manager, was responsible for managing Primus s Corrective Action and Preventive Action program. I oversee the document control function to include organization, maintenance, and retention of records. Develop sampling plans by applying attribute, variable, and sequential sampling methods. Prepare reports by collecting, analysing, and summarizing data, making recommendations based on analyses.
Reporting trending of quality related metrics to upper management (complaints, change orders, product defects, etc.).
Managing Primus Approved Supplier System and conduct supplier audits. Were the Chairperson for the Management Review meetings that were conducted at Primus Medical?
Was tasked to ensure the quality awareness through cost effective training of Primus s personnel. Provided functional input during development project planning to accurately assess resource and scheduling considerations. Partnered with Product Development and other cross-functional team members to define design input (i.e., Customer, System, Hardware, and Software Requirements). Review and approve design input and design output documentation.
Partner with Product Development, other cross-functional team members and consultants/external test houses to define design verification and validation testing.
Assisted in the execution of dry runs and in oversight of official V&V testing. Review and approve verification and validation test plans and test reports. Represented quality assurance as the lead quality assurance team member in design review and phase review meetings.
Drove project/system level risk management deliverables (i.e., plans, Device Hazard Analyses, reports, and Risk Management). Reviewed and approve other cross-functionally developed risk management deliverables (i.e., uFMEA, pFMEA, IEC-60601 Requirements).
Reviewed and assess all proposed changes (i.e., Change Requests, Special Rework Instructions) to ensure proper level of testing supports implementation. Verified development project documentation was following Company procedures.Primus Medical LLC, Boardman OH Apr 2012 - Feb 2013Manufacturer / Quality Engineer
Was the on-site trainer and manufacturing/quality support for Primus Medical LLC in Xiamen China. Was responsible for providing leadership and guidance in implementing actions for the quality management system in China.
Site trainer for corrective action and preventive action, manufacturing certification, Lean Manufacturing, Total Productive Maintenance (TPM) and related quality functions.
Would advise on-site top management team on how to conduct management reviews and guiding them on how to improve and grow their quality management system.
Trained and coached the work force on how to verify and validate their processes, procedures, and work instructions to comply with the medical device standard.
Provided functional input during development project planning to accurately assess resource and scheduling considerations.
Partnered with Product Development and other cross-functional team members to define design input (i.e., Customer, System, Hardware, and Software Requirements, IEC-Requirements).
Review and approve design input and design output documentation. Partner with Product Development, other cross-functional team members and consultants/external test houses to define design verification and validation testing.
Assisted in the execution of dry runs and in oversight of official V&V testing. Review and approve verification and validation test plans and test reports. Represented quality assurance as the lead quality assurance team member in design review and phase review meetings.
Drove project/system level risk management deliverables (i.e., plans, Device Hazard Analyses, reports, and Risk Management). Reviewed and approve other cross-functionally developed risk management deliverables (i.e., uFMEA, pFMEA).
Reviewed and assess all proposed changes (i.e., Change Requests, Special Rework Instructions) to ensure proper level of testing supports implementation. Verified development project documentation was following Company procedures.Other Related Quality Medical Devices Companies worked for with the Responsibilities:Responsibilities: Whether it was in ISO9001, ISO13485, 21 CFR Parts 803, 806, and 820, European Medical Device Directive (93/42/EEC) and European Medical Device Regulation (EUMDR) 2017/745, along with Canadian Medical Devices Regulation (SOR/98-282)Contract Manufacture Engineer, St Jude Medical, Plano TX. 2011 -2012 Contract Quality Manager, Northern Indiana Manufacturing, Bourbon, IN 2011 2011Contract Validation Engineer, Symmetry Medical Inc., Avilla, IN 2010 2010Contract Quality Manager/Engineer, DEW Technologies Inc., Fairborn, OH 2009 2010Contract Quality Engineer, Stryker Orthopaedics, Mahwah, NJ 2008 2009Quality/ Mfg. Manager, Dynamic Metals LLC, Elkhart, IN 2007 2008Quality/ Mfg. Engineer, Paragon Medical Inc., Pierceton, IN 2005 - 2005Quality Engineer, Medtronic Spine and Bio, Warsaw, IN 2002 - 2005Quality Engineer, Synthes USA, Monument, CO 1995 - 2002Military Experience:U.S. Army 1977 - 2016 Tank and Automotive Maintenance Manager and Civil Affairs Officer Served in Desert Storm, Bosnia, and Iraqi Freedom.
Retired Major of Ordnance and Civil Affairs. 40 years of automotive repair and testing as well as planning and deployment of military assets and personnel.Assignments include: Chief of the DOD School for Machining and Welding, APG, Md. G3 Operational Development and Planning Officer, Ft. Carson, Co. Recovery/Redeployment Officer for Equipment Mobilization, Iraqi Chief Training Officer for Troop Preparedness, Bosnia Provisional Reconstruction Planning and Development Officer, Iraqi |
