SUMMARY

• Expertise in management and manufacturing functions, cost avoidance, internal and external audits, multi - cultural environments, process validation, problem solving, quality systems, and program management.
• Knowledgeable in top medical devices such as contact lenses, weight scales, pelvic muscle trainer, professional and consumer thermometers, blood pressure machinery, heating pads, and water purification and air purifiers.
• Extensive knowledge of processes, procedures, and policies necessary to consistently produce a superior product and service.

CORE COMPETENCIES

• Supplier Quality Engineering
• Quality Standards, GMP
• Vendor Relationship Management
• 21-CFR-820, 21-CFR-803
• ISO 9001:2008
• ISO 13485
• Lean Manufacturing
• Process Review / Improvement
• FMEA, MSA, SPC, DFMEA, PFMEA, APQP, PPAP
• Internal and External Auditor
• Project Management
• Six Sigma Green Belt
• Certified Lead Auditor
• CAPA Robustness

PROFESSIONAL EXPERIENCE:

Confidential, Miami, Florida

Supplier Quality Engineer

Responsibilities:

• Manage supplier quality standards, processes and procedures. Ensuring hardware of trauma and spine met system requirements through effective and timely investigation of CAPAs, non-conformances, and complaints. Established disposition of non-conforming materials including analyzing non-conformance for fit, function, safety, and reliability, as well as communicating with Quality Assurance and suppliers as required. Validate manufacturing and engineering functions, to ensure specification and documentation requirements.
• Provide support to inspection department on drawing interpretations and inspection methods. Partnered with R&D and Quality Assurance to ensure new product sourcing and supplier controls were implemented and in line with business requirement. Developed training for Majesty CRM software and trained new employees to use Majesty software. Validated design history files for goods receipts, shop orders, and re-processing sets returning from the field.

Confidential, Marlborough

Senior Quality Engineer

Responsibilities:

• Manage quality of health care devices for Professional and Consumer thermometers under the brand name Braun; Humidifiers under brand names Vicks, and Honeywell, also water purification for consumers under brand name PUR. Developed partnerships with CVS, Amazon, and Welch Allyn for product development, quality issues and new product launch. Program risks were identified, and validated actions were active before product launch of my projects. Partnered with engineering, suppliers, and sourcing on product launch and material pipe line flow.
• I lead commodity reviews, develop lessons learned at project end, and partnered with new product engineering teams on next generation development and guided engineering with design assurance recommendations. Evaluated Welch Allyn return’s data to select specific serial numbers for advanced analysis on Professional devices to gain insight on “in- field” symptoms for this ground-up project. Provided response to internal CAPA’s and provided evidence of actions, closure, and effectiveness

Confidential, FL

Supplier Quality Compliance Auditor

Responsibilities:

• Conduct, execute and close supplier on-site and desktop audits. Validated effectiveness of CAPA implementation on prior audits
• Compile audit reports, work with SME’s for shared audit expertise and execution.
• Generate audit timeliness, effectiveness checks, adherence, and aging prior to month close.
• Managed revision of 18 documents, filtered through Medical Device & Diagnostic division of J&J.
• Merged Audit schedule with Risk Matrix, to develop 2015 audit schedule while monitoring Risk Matrix monthly.

Confidential, Atlanta, Georgia

Quality Assurance

Responsibilities:

• Managed quality document development to reflect Duke Energy’s new standards; on four projects, for 2014 launch.
• Utilized PPAP techniques to ensure new material and processes were qualified across 5 states.
• Created Quality Assurance Plans, Quality Management Manual, Internal Specification template, and Inspection Test Plans on four projects.
• Collaborated with Program manager, Sourcing, Engineering, IT, Business Analyst, and Telecomm for their input to create new documentation.
• In parallel, re-designed their internal / eternal audit questionnaire, added Analytical Hierarchy Process model to normalize scoring, eliminated emotional input and embedded self-generating metrics for presentation to management.
• Formulated 125 powerful eternal audit questions related to Software and Program management categories. Managed Corrective Action Preventative Action deliverables from Software supplier processes, insuring their robustness of CAPA.
• Conducted QA/QC inspection on Meter Housing, and enclosures in the field. I contributed to Statements of Work for new projects and suppliers, also developed Supplier Scorecards, and maintained monthly metrics.
• Established qualification criteria for suppliers move to Mexico facility.

Confidential, Boca Raton, FL

Senior Design Assurance Engineer

Responsibilities:

• Managed Medical Devices Product Start Authorization (PSA) for baby nebulizers, heating pads, pelvic muscle trainer, hot / cold packs, digital thermometer in pacifiers, and blood pressure cuff.
• Using APQP for specification development to isolate customer and regulatory requirements; develop QA section of product specification; qualification matrix to individual protocols, and validate marketing callouts for medical device packaging. Provided direction to 12 quality engineer’s (in Asia) adherence to PPAP, product quality standard and develop improvement strategies to raise customer satisfaction, reduce defect rates, and streamline supply chain procedures. Maintained DHF as evidence of CAPA solutions for historical non-conformance records.
• Identified KPI, CTQ, customer requirements, and conducted gap analysis for third-party testing. Managed design reviews on proto type builds, established reliability warranty percentages on New Product, and oversaw technical capability review of new suppliers.
• Escalated non-conforming product and customer complaints to suppliers for Root Cause & CAPA follow up / closure. Updated procedures to reflect 2011 & 2012 guidelines for medical devices and reflected FDC guidelines. I validated DHF for accuracy, accessibility, signatures, and managed transition from design phase - proto phase - production launch, and final qualification of product.
• Developed and executed QFD (quality functional deployment), and scorecards, conduct SFMEA; GR&R; DFMEA; Product metrics and maintain DHF for ISO 13485 FDA audit. I qualified first off tool component meet specification design requirements.

Confidential, Boca Raton, FL

Senior Quality Engineer

Responsibilities:

• Ensured products met FDA, FCC, Consumer Product Safety Commission, and Consumer Product Safety Improvement Act regulations by collaborating with suppliers, Confidential Asia teams addressing Quality issues.
• Re-designed the corporate quality manual reflecting new Oracle processes, tracking, data collections, factory quality audit documentation to focus on luggage, seating, writing instruments, and shredders.
• Managed CAPA corrective actions were appropriate, robust to contain/eliminate non-conformance and were enforced. Validated third-party lab results met customer requirements, and specification’s
• Created 52 Oracle collection plans to capture non-conformances, generate CAPA’s, and develop effectiveness checking of CAPA implementation. These collection plans allowed Metric development, Historical trending over time, and were compared to on-line complaints.
• Recovered $350,000 in charge backs for 2010. Facilitated on-site quality reviews of suppliers and their outsourced manufacturing partners. Lead supplier capability assessments and audits in US, and Asia.
• Certification Lead Auditor ISO 9001:2008. (IRCA).

Confidential, Plantation, FL

New Product Introduction & Sourcing Engineer

Responsibilities:

• Lead new product introduction and supply readiness on electrical components.
• Qualified suppliers through capability assessment audits, data evaluation, and historical analysis.
• Met cost, quality and scheduling goals for each project and drove cost reduction on electrical components.
• Supported development engineering, category management, and suppliers to qualify material for program launch. Managed supplier and supply chain issues, and drove supplier selection on new programs, and tracked cost reductions. Visited NPI suppliers to qualify first off tool components meet design requirement, and supported NPI transition to full blown production.
• Using PPAP tool, validated qualification requirement of raw material, components and sub-assemblies to achieve “Dock to Stock” standard with no pre-inspection. Managed closure of CAPA’s for New Product Introduction.
• Partnered with Supply Chain on APQP for supplier risks on purchased material, and set qualification baseline.
• Understood Design Engineering needs, and assisted with supplier negotiations on qualification of new products.
• Performed analysis of newly acquired Connected Homes, for their QA/QC resource needs. My recommendations of 5 additional head count were added to Connected Homes 2006 budget.
• Trained 5 Asia sites Confidential inspection processes to assist 3 Confidential divisions on cosmetic inspection.
• PPAP techniques used for improvements at Asia sites to insure out-going product met the highest quality possible.
• Lead capability assessments of suppliers to provide justification of awarding new business, qualifying or disqualifying suppliers. Developed improved inspection methods, process control techniques, SOP’s, inspection plans, test protocols and test reports to ensure safety, reliability and efficacy of new and current products and processes.
• Audited supplier capability, conducted on-site inspections looking for inconsistencies.
• Awarded Six Sigma Green Belt in 2003
• Managed incoming quality inspections, audit findings / observations, non-conformances and corrective action implementation. Managed supplier’s validation of CAPA’s, through tracking of non-conformances for effectiveness of CAPA solution. CAPA robustness is the key to eliminate non-conformances throughout suppliers’ facility.
• Used data driven decision making to achieve cost reductions problem solutions and continuous improvements with Lean and Six Sigma Tools. Compared designs to engineering standards, prints, and schematics.
• Worked with problematic supplier to find their quality gaps, by evaluating their internal data. Taught suppliers how six sigma tools would improve their outgoing quality, and helped them institutionalized quality improvements.
• Drove supplied material issues to root-cause analysis, corrective action, and cost of poor quality, and recovered in excess of $5,000,000 over a four-year period.
• Supported internal and external audits such as KEMA, BABT, ISO, QSR, TL9000, and Sterling (Florida equivalent to Malcolm Baldrige award).
• Traveled to suppliers for qualification of first article components, and determine if first off tool component met design requirement for injection mold on housing, lenses, antenna’s and keypads. Conducted effectiveness’ checks of CAPA’s