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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Menecal AveSt. Augustine Fl Street Address
Cell: PHONE NUMBER AVAILABLEEMAIL AVAILABLECareer Summary: 39 years within the IndustryQuality Manager: Supporting all listed disciplines stated in the job descriptions below.:Systems Process Manufacturing Engineer:Certified FDA Sr. Principal SME Level IV:Supplier Quality Engineer:Validation /Remediation EngineQMS: QualityEngineer, re-wrote the QMS for 21 suppliers for Medical Compamies for a major Medical Manufacturer which cover all seven principals outlining the specifics: Quality Policy, Explanation of the companies documentation structure, Organizational Chart, Policy Statement applicable to the ISO requirements, Referencing to Operating Requirements, covering ISO 9001:2015, ISO 13485. Customer Focus, Leadership, People involvement, Process Approach, Systemic approach to Management, Continual Improvement, Factuall Approach to Decision making, CAPA activity.Title: Independent Engineeering Consultant 1-8-2020 to presentAssisting former assocaites with ad hoc projects. CAPA, IQ,OQ,PQ, PPAP, Assessments, QMS Validations, Auditing, amd Remedation.Title: Contract Principal SQE IV Engineer / Auditor 9-11-2019- 1-8 2020Oxford Global Resources LLC. 100 Cummings Center, Suite 2061., Beverly MA. 01915Site Contracted to: Veran Medical Technologies 1908 Inner Belt Business Center Drive Overland Mo. 63114Supplier Quality Validation / Remediation, overseeing 2 Medical Suppliers review for FDA compliance utilizing 21 CFR Part 11 / CFR Part 820. Supplier on site external validations implementing Quality Systems Regulations: (SME) Subject Matter Expert: SMT Processes. General Provisions, Quality System Regulation, Design Controls Support, Document Controls / EDMA, CAPA, TMV Testing, Pre-Market Approval (PMA), UDI Marking, Nonconforming (NCMR), implementation Medical Device Regulation (MDR) 510(K) team member. Products included non-invasive exploratory lung regions for biopsy.Title: Supplier Quality Engineer Contingent 2-20-2017 / 2-18-2019Redbock Consulting21730 Steven Creek BlvdCupertino Ca 95014Site Contracted toMedtronic Inc. ENT Xomed DivisionJacksonville FL 32216Contingent SQE fulfilling a long-term contract to support ENT (Ear Nose Throat) product process controls. SME for PCBA, Cable applications, CAPA, Supplier FAI approver, UDI and Dock to Stock process improvements. Internal Process Validations, Validation of External Supplier Site auditor for Quality Process Review for re-qualification realign to meet Dock to Stock program requirements. MRB / SAP application approver for NCMR dispositions. Product Flow Chart, Control Plan, PFMEA, Supplier approver for IQ, OQ, PQ qualification. PPQP technical Engineer supporting Supplier AVL. Protocol implementation and review of Suppliers application for FDA compliance. Support specific Suppliers to maintain qualification, with review of quality compliance metrics utilizing Mini-Tab, Agile, Sap software applications. Certified in the following: 21 CFR 820, CAPA.UDI: Supported EUMDR project team (M.E., R&D Engineering, Project Management, Procurement Management, Regulatory) as the Supplier Quality Engineer covering 1200 individual products. Daily activity included, the following reference the protocol EU 2017/745 ISO 14155:2011 including all articles and annexes applicable to the standard: Process Validations /Remediations methodologies and protocols supporting GTIN marking requirements outlined by Research and Development redline drawings as approving member of all documents: IE: Process of Records supplied to Medtronic. Responsible for all Supplier First Article requirements with all required documents, approvals of FAIs, Packaging / Markings and associate documents shipped to Medtronic. Reviewed all methods of markings processes, Etch, Laser, Metalized and Bar coding. Approval team member for all ECO / ECR activity utilizing Agile software. Implemented CAPA activity as required. Completed the 1200 product requirements within the project time frame.Title: General Manager RD Altanova-Assembly PA 2-14-2016/1-4-171660 E. Race StAllentown PA 18109Manage a staff of 9 Managers / 5 which are Sr. Staff: 31 total employees: Assess and rebuild former manufacturing facility to exceed World Class Status: Design and align the floor plan to optimize the efficiencies to meet Customer Scheduling expectations, Quality, and Customer Service. Evaluate antiquated SMT equipment and bring them up to todays industry standards. Create Process of Records to instill repeatability to develop history and Product Realization. Assess each employee for untapped skills and reassign them to value added status. Mentor the new Management team to their job roles. Maintain a working budget 6M. Train employees with new technologies. Change the culture to a positive approach by instilling guidance and trust in each department. Create strong customer relations. Continual support to both internal and external customer and supporting divisions. Create cycle times for build capabilities utilizing Lean GMP, GDP, utilize Takt time studies to ensure quoting cost are met or exceeded. Maintain an accurate inventory levels using a pull system of Kanbans. Support DFM activity, Sales and Design with PCOLA activity. Develop DOE concepts for all NPI. Oversee the action to recover ISO 2015 with all associated documentation. Oversee all building upgrades to meet Pennsylvania Township local requirements with permits. Lead by example, listen, and learn from each employee to ensure team capabilities and success.Title: Quality Manager Uni-Fab Industries 1-5-2015 2-19-20165020 Branden Ct.Fremont Ca. 94538Full charge Quality Manager supporting an all inclusive Metal Manufacturer, Heat Treating Process, Welding, Cleaning, Laser Cutting, Fabrication, Assembly of main frames, Audit outside Suppliers IE: Paint, Coatings, Alodine-Anodize Processes, Charge of full Receiving Mechanical Inspection Department utilizing state of the art measuring equipment,Gage R&R Validation, Internal ISOAuditing. Create and develop all QMS activities to support all internal and external customers. Secure lost ISO to the latest ISO 2015 version including all SOP and supporting documents. Direct Process controls liaison contact to Intel / Lam Research.Title: FDA Principal SQE IV Engineer / Auditor/ SME 3-19-14 11-21-2014Oxford Regulatory & ComplianceChandler AZ.Site Contracted to: Terumo Cardiovascular Division6200 Jackson RoadAnn Arbor. Michigan 48103Supplier Quality Validation / Remediation, overseeing 5 Medical Suppliers review for FDA compliance utilizing 21 CFR Part 11 / CFR Part 820. Supplier on site external validations implementing Quality Systems Regulations. FDA Certified: (SME) Subject Matter Expert: SMT Processes. General Provisions, Quality System Regulation, Design Controls Support, Document Controls / EDMA, CAPA, TMV Testing, Pre-Market Approval (PMA), UDI Marking, Nonconforming (NCMR), FMEA implementation for suppliers.ISO Medical Consultant/Manager:Quality Circuits Assembly (3mth Contract) 1-4 -14 to 3-04-141709 Junction Ct.San Jose. CARecover neglected QMS to ensure re-certification for Medical Compliance to support ISO 13485/14971: MDD-MDR / EC / FDA / PFMEA, DFMEA, FMEA / CAPA / ITAR: Supported the Trama Centers for Cardiovascular, Thoracic, Ear Nose and Throat products through Remediation Production of Suppliers.Title: Senior Lean Process Manufacturing Engineer 12-10 to 10-13Supplier Quality ManagerMultitest3078 Kenneth StSanta Clara Ca 95054Responsible for Management of Suppliers and Sub-contractors Manufacturing for compliance to Intel Automation Test Equipment (ATE) PCBAs. Developed and instilled Lean Manufacturing disciplines in the assembly division and sub-contractors sites. Supplier Qualifications / Surveys, qualifying to the component level for GMP utilizing SOP, IQ, OQ, and PQ. Managed worldwide factories in implementing 5S, Kaizen, PCOLA Review, CAPA, FMEA, 8D Reporting, Six Sigma, Kanban systems.Title: ISO Consultant Medical PHONE NUMBER AVAILABLE Risk (Contract) 6-10 to 12-10Airtronics Welding and Manufacturing: Completed gap analysis to secure Medical ISO 13485, re-wrote the entire QMS for compliance and completed all 8 elements internal audits in preparation of the ISO audit. Supporting BAE for Military applications compliance to meet ITAR requirements of products to support overseas activity during Military engagement.Title: Senior Quality Engineer(7 month contract due to medical considerations) 3-08 to 10-08Paramit Corporation18735 Madrone ParkwayMorgan Hill Ca. 95037Responsibilities: Supported full manufacturing processes in maintaining quality to meet Paramits DPMO. Total Quality support to two OEMs products lines from design to full integration. Mentored junior engineering staff, maintained all ECO activities and quality requirements for each specific customer including monthly quality metrics review to drive Kaizen.Surgery for Vestibular Neuritis 6-05 to 2-08Full recovery, with no affect to motor skills.Title: Director of Operations / Quality Manager / Manufacturing 2-01 to 1-04Foxconn Backplane Division1688 Richard Ave.Santa Clara, Ca. 95050Responsibilities: Full charge of all daily operations regarding Profit & Loss, yearly operating budget $6.7m. Directly responsible for interactions with our main customer Cisco, created QMS and all Processes of SMT, Wave, Press Fit, and Test regarding Manufacturing and Quality for NPI and China production. Trained all personnel in the USA and China facilities, qualified all suppliers and vendors via site surveys. Controlled all Regulatory requirements where applicable ISO, UL, CSA, TUV, Bellcore, and BABT. Transferred production to our China facility with all documentation based on Lean Manufacturing / Flow Technology. Created and trained all China personnel on documentation to meet Ciscos qualification process by GSMs, responsible for the growth of revenue under my tenure to $500M.Education:San Jose State CollegeBachelor of Arts: Science/PsychologyCalifornia Dan Ryan Teaching Credential: Electronics / Drafting / MathFDA Class Certifications: CAPA, SCAR, NCMR, ECO/ECR, PPQP, MDR, ITAR, APQP.Certified Lean Trainer for Flextronics International SMT applications to build Cisco products.Additional Job information upon request: |
