Sr Quality Engineer

ANA PAMELA DAVILA-SKAAR

Sr Quality Engineer

**** ****** **., ********* ** 53959

Email: *********@*******.*** I Phone: 920-***-****

Experience

MEDTRONIC Inc. (Sr. Quality Engineer Mar 2014 – Mar 2018)

**Global leader in manufacturing and marketing of medical devices designed to alleviate pain, restore health and extend life.**

Provided exceptional support as Sr Quality Engineer to 8 manufacturing lines (CVG) ensuring compliance of regulatory requirements and GMPs; Accomplished permanent elimination of many Non-conforming events through investigation and documentation of NCRs, developed a thorough knowledge of scope definition, risk assessment and root-cause analysis, as well as corrective/preventive action implementation; Effectively drove and completed CAPA projects to eliminate sources of product/process quality issues; Managed product and material disposition, as well as planed deviations; provided resolution to post market activities including complaint processing and investigation; Improved KPI metrics (RTY, CPMs, NCR rate, among other) by ongoing monitoring and process improvements; effectively reported quality issues, trends and status of corrective/ preventive actions to management and higher organization tiers; provided support for testing and process validations (PC, OQ, PQ, IQ) for new product development projects; Developed and maintained quality and manufacturing procedures; Attained processes optimization through FTQ; Achieved significant cost reduction of destructive testing through DMAIC. Effectively managed 15+ quality inspectors.

Achievements:

- Achieved +$330K annually cost reduction of destructive Pyrogenic (LAL) test for NC Sprinter Rx and Sprinter Legend Rx product families by validation and sample plan reduction.

- Obtained Logistic/ operation cost reduction by completing Bioburden test validation for 6 POBA catheter product families to be performed locally in Medtronic Mexico.

- Eliminated product traceability issues by Implementing System/Scan verification station for packaged Finished Good’s

- Reduced up to 70% of the top contributor defects impacting RTY through FTQ

- Eliminated packaging contamination issues reported by customer hospitals by reengineering a manufacturing line.

- Eliminated print on demand process breach issues by modifying process flow of final packaging work stations and applying restrictions to print on demand software.

- Actively participated in the Following Product Development projects:

NC Euphora¬ and SC Euphora Rx EZ Pull (Packaging/Labelling Project)

NC Solarice Rx and Solarice Rx (Product Development Project)

NC Solarice Rx and Solarice Rx Canada (Packaging/Labelling Project)

Stentex ST Dylacor and ST Emercor (Product Launching Project) - Attained Excellence Award in January 2017

- Actively Participated in Investigation, Corrective actions, and resolution of a Field Corrective action impacting +300K sold units

MUTSUTECH (Quality Systems Engineer Jul 2013 –Mar 2014)

**Full Service Company of plastic injection molding**

Leaded internal and external audits for quality and environmental systems ( ISO 9001, ISO TS16949 and ISO 14001); Developed statistical key indicators for process productivity, quality control, customer satisfaction, supplier performance, competence and training; Follow up on objectives and targets for quality system; Coordinated Management review meetings; Lead audits from local and foreign customers; Completed multiple 8D analysis and followed up on corrective actions; Responsible for revising, updating and creating Quality Control procedures; In charge of document control and record management; Responsible for developing IMDS data sheets for automotive products; Support Project Engineering with PPAP, APQP and R@R audit; Assist quality control department in daily activities including disposition of RMA, quality and environmental customer surveys, follow up on corrective actions to suppliers upon non-conforming material, process patrolling, 5S, among others.

LEAR CORPORATION (Quality Engineer Jun 2012 –Jul 2013)

**Leading global supplier of automotive seating systems and electrical power management systems**

Developed and implemented quality system; Managed and trained 12 + inspectors; Responsible for setting up containments, generate quality alerts and VOC communicating non-conforming conditions to quality team upon a customer complain; Leaded the annual process walk to update PFMEA and Control Plan, attacking high risk contributors to prevent recurrence of quality issues; Implemented poka yokes and new technologies to improve detection; Investigated and determined final disposition for non-conforming material at MRB.

MAGNA COSMA INTERNATIONAL (Quality Engineering Internship – Jan – Jun 2012)

**Global Automotive Supplier leader in the production of quality metal stamped and welded part assemblies**

Collaborated in the Engineering Department as part of Ford CD4 (Ford Fusion and Lincoln MKZ 2013) Launching PPAP project preparing engineering design records, production process and quality documentation (Gauge R&R, dimensional, Process Cap studies) and Supplier technical assistant audits, for stamping/assembly production lines to demonstrate process potential to produce products consistently meeting Customer’s specification during an actual production rate; Collaborated in the creation of PFMEA, Control Plan, Process Flow diagram, Visual Aids, Standardized work sheet to document the work process of all the assembly production lines in accordance with the standard ISO TS/16949 and AIAG manuals; Performed a DMAIC project as part of a Six Sigma Green Belt Certification Program to eliminate defects caused by welding process deficiencies.

Languages

English (Fluent), Spanish (Fluent) and some German

Education University of Wisconsin-Platteville, Platteville, WI

B.S. Industrial Engineering (Study Abroad Program) ~ Fall 2011

Universidad de Sonora – Hermosillo, Mexico

B.S. Industrial and Systems Engineering ~ Dec. 2012

Certifications Six Sigma Green Belt certified

Orange Belt – Lean Manufacturing

Yellow belt – Problem Solving Tools

ISO9001 Internal Auditor

ISO14001 Internal Auditor

TOEFL 567 Points

Software

Statistical and Data Analysis Tools (Minitab and Microsoft Excel) Computer Assisted Design (AutoCAD Autodesk)

Microsoft Office Suite

SAP(ERP System)

Print on Demand (Scan of Packing)

Summary of Qualifications

Responsible, reliable, organized professional with

• Excellent interpersonal, oral, and written skills with ability to effectively communicate with colleagues at all levels and of all cultures

• Sense of Urgency

• Good working knowledge of FDA and international medical device regulations

• Expertise in Problem Solving Tools and Continues Improvement methodologies (Process Review, Cause and Effect Analysis,5 whys, Prioritization Matrix, A3, VSM, DOE and DMAIC)

• Exceptional reporting, meeting and motivational skills

Team player and leader, who enjoys working in a fast-paced environment, with ability to

• Manage multiple projects and prioritize based on deadlines

• Learn fast and adapt to new perspectives

• Follow company policies, procedures and methods of hazard and risk management

• Travel in foreign countries

Interests

Product Development Projects

Process and Product Validation

DMAIC

Quality Audit

Tech Transference

CAPA

NCR

Personnel Management

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