Bob Pendleton work email
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Bob Pendleton personal email
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Summary of Qualifications: An accomplished Six-Sigma Green Belt Quality Professional with extensive background in Project Management. Dynamic leadership skills and problem-solving abilities. Experienced communicator with practical experience in the execution of Six-Sigma, Lean Manufacturing and Kaizen Projects. Skilled in Design Control, Risk Management, Validation Protocol, FMEA, APQP, PPAP, SPC, DOE, and Gage R & R. Coordinated the implementation and management of ISO 9001, ISO 13485, TS 16949 and AS 9100 Quality Systems. Developed Training Programs in Quality Systems, Internal Auditing, Supplier Auditing/Certification and Statistical Quality Tools. Applied Regulatory knowledge with GMP, QSR, ISO, DOD, UL, CSA, ETL.Specialties: AS 9100, Calibration, CA/PA, Continuous Improvement, Design Control, Design of Experiments, FMEA, Internal Auditing, ISO 9001, ISO 13485, Kaizen Events, Lean Manufacturing, Minitab, Project Management, Six Sigma, Statistical Process Control, Statistical Analysis, Supplier Audits, Supplier Certification, Validation Protocol, Risk Management, Training,
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Sr. Quality Assurance EngineerMarizyme Inc Oct 2021 - Apr 2024Jupiter, Florida, UsI was a part of a team working to incorporate a Medical Device into an ISO 13485 Quality System. My responsibilities included:• Creating Quality System Documents, Work Instructions, Forms, Records and Templates• Supplier Audits• Nonconformances• Corrective & Preventive Actions• Change Control• Management of Document Control Room• Management Review -
Sr. Quality Assurance EngineerTecomet, Inc Jul 2021 - Oct 2021Wilmington, Ma, UsI was a part of a validation team working to incorporate newly manufactured components into an ISO 13485 Quality System. My responsibilities included:• Process Verifications• Process Validations• Design of Experiments• Creating Protocols & Test Reports • Performing Test Method Validations -
Senior Supplier EngineerSio2 Material Science May 2021 - Jul 2021Auburn, Alabama, UsI was part of the Quality Group that had the following responsibilities:• Process Validation Protocols• Internal Auditing.• Inspection Plans.• Change Control • Writing Procedures & Work Instructions • CAPA Remediation -
Senior Design EngineerFreudenberg Medical Feb 2021 - May 2021Beverly, Massachusetts, UsI was part of the Design Group at Freudenberg Medical working on projects for Medtronic and Boston Scientific. My responsibilities included:• Design Reviews• Deviation Reports• Verification and Validation• Protocol Writing• Technical Report Writing.• Test Method Validations• Gage R & R -
Sr. Supplier EngineerPfizer Dec 2019 - Feb 2021New York, New York, UsRemediation effort associated with FDA 483 Warning Letter concerning supplier quality agreements of combination products. Responsibilities include:• Performing review and gap analysis of existing quality agreements to QSR requirements.• Creating amendments to quality agreements. • Facilitation of amendments with applicable Pfizer organization and affected suppliers. • Updated internal systems upon approval. -
Senior Quality EngineerOrchid Orthapedics Aug 2019 - Dec 2019Review and update Quality Management System to comply with QSR and ISO 13485. Activities include: • Preform gap analysis of Supplier Management System• Review existing procedures/work instructions for compliance to QSR and ISO 13485• Create Audit Schedule • Audit Critical Suppliers• Manage Supplier SCAR System• Created Incoming Inspection Work Instruction• Trained inspection team members of required inspection methods and sampling plans
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Senior Supplier EngineerPhilips Apr 2019 - Jul 2019Amsterdam, Noord-Holland, Nl• Creation of Supplier Inspection Plans. • Facilitated Interplant Product Transfers with appropriate Inspections & documentation.• Verified & Validated New Product Designs.• Performed Statistical Analysis & Generated Technical Reports -
Senior Supplier Quality EngineerPhilips Nov 2018 - Apr 2019Amsterdam, Noord-Holland, NlThis was a Start-Up, Class III Pharmaceutical/Biologics company. My responsibilities included:• Performed Gap Analysis of QMS for Regulatory Compliance.• Wrote Procedures & Work Instructions.• Process Mapping of Drug Operations to identify Inherent Risks.• Facilitated dFMEA & pFMEA Activities. • Created Critical Parts Lists.• Developed Supplier Approved Vendor List.
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Senior Quality EngineerCreosalus Jan 2019 - Apr 2019This was a Start-Up, Class III Pharmaceutical/Biologics company. My responsibilities included:• Performed Gap Analysis of QMS for Regulatory Compliance.• Wrote Procedures & Work Instructions.• Process Mapping of Drug Operations to identify Inherent Risks.• Facilitated dFMEA & pFMEA Activities. • Created Critical Parts Lists.• Developed Supplier Approved Vendor List.
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Senior Validation EngineerLake Region Medical (Integer) Aug 2018 - Nov 2018I was part of the Quality Assurance Group involved with the creation and execution of IQ/OQ/PQ CMO Validations. My responsibilities included:• Writing and Executing IQ/OQ/PQ Validation Protocols with CMOs. • Performed Statistical Analysis.• Wrote Technical Reports. • Generated NCRs.• CAPA/SCAR Remediation.
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Sr. Supplier Quality EngineerThermo Fisher Scientific Apr 2017 - Aug 2017Waltham, Ma, UsI was part of the Quality Assurance Group involved with the management of the Supplier Corrective Action Program. My responsibilities included:• Supplier Management. • Supplier Audits of NCR’s, IR’s and DR’s.• Maintained and Results of Monthly Metrics of Suppliers. • Performed IQ/OQ/PQ Validations of Raw Materials & Modified Components.• Qualified Supplier Development of New or Modified Components. -
Sr. Quality EngineerZimmer-Biomed Dec 2016 - Mar 2017I was part of the Quality Assurance Group involved with the management of the Supplier Corrective Action Program. My responsibilities included:• Supplier Management. • Supplier Audits of NCR’s, IR’s and DR’s.• Maintained and Results of Monthly Metrics of Suppliers. • Performed IQ/OQ/PQ Validations of Raw Materials & Modified Components.• Qualified Supplier Development of New or Modified Components.
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Sr. Product Development EngineerDepuy Synthes Apr 2014 - Dec 2016Participate in Design Review Phase as part of Risk Management remediation.
Bob Pendleton Skills
Bob Pendleton Education Details
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Central Western UniversityIndustrial Engineering -
Worcester Polytechnic InstituteProject Management Certified
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West Boylston Jr. Sr. High
Frequently Asked Questions about Bob Pendleton
What is Bob Pendleton's role at the current company?
Bob Pendleton's current role is Looking for a Senior Quality Engineer or Quality Manager role..
What is Bob Pendleton's email address?
Bob Pendleton's email address is ro****@****zer.com
What schools did Bob Pendleton attend?
Bob Pendleton attended Central Western University, Worcester Polytechnic Institute, West Boylston Jr. Sr. High.
What skills is Bob Pendleton known for?
Bob Pendleton has skills like Quality System, Spc, Six Sigma, Lean Manufacturing, Continuous Improvement, Fmea, Iso, Supplier Quality, Iso 13485, Manufacturing, Design Of Experiments, Quality Assurance.
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