Alexandra Wright

Alexandra Wright Email and Phone Number

Quality Engineer at Entegris @ Entegris
billerica, massachusetts, united states
Alexandra Wright's Location
Greater Colorado Springs Area, United States
Alexandra Wright's Contact Details

Alexandra Wright work email

Alexandra Wright personal email

n/a

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About Alexandra Wright

A dedicated quality engineer and people leader with experience in Medical Device Quality Systems with passion for leadership and process improvement. Focused on utilizing a background in lean principles and biomedical engineering to deliver advanced solutions in the quality space.

Alexandra Wright's Current Company Details
Entegris

Entegris

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Quality Engineer at Entegris
billerica, massachusetts, united states
Website:
entegris.com
Employees:
3353
Alexandra Wright Work Experience Details
  • Entegris
    Quality Engineer
    Entegris Nov 2022 - Present
    Colorado Springs, Colorado, United States
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  • Hollow Leaf Art
    Founder, Principal Artist And Designer
    Hollow Leaf Art Apr 2022 - Present
    Instagram: @hollow_leaf_artWebsite: hollowleaf.art
  • Philips
    Senior Engineer, Supplier Quality
    Philips Jun 2021 - Oct 2022
    Colorado Springs, Colorado, United States
    • Manage over 100 suppliers that provide components for consumable devices and laser capital equipment for image guided therapy• Maintain approved supplier list, coordinate new suppliers for approval, assess supplier change requests and manage quality system records for each supplier• Compile supplier quality metrics for six North America sites• Deliver metrics presentations to global leadership team each month• Foster collaborative relationships with suppliers to drive quality improvements, corrective and preventive actions (SCAR)
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  • Jabil
    Quality Engineering Leader
    Jabil Jun 2019 - Jun 2021
    Monument, Colorado
    • • Served as supervisor and manager for team of twelve quality engineering professionals supporting multiple areas of medical device manufacturing• Communicated weekly and monthly quality metrics to key stakeholders both internally and externally• Utilized data driven approach to steer business/project decisions and team focus• Delivered quality solutions with cross-functional teams to support manufacturing operations• Provided audit support in both Front Room (Scribe, Subject Matter Expert) and Back Room (Back Room Leader, SME Prep, Document Review)• Led and collaborated on quality system improvements and investigations (PFMEAs, Root cause analysis, Validations)
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  • Jabil
    Senior Quality Engineer
    Jabil Apr 2019 - Jun 2019
    Monument, Colorado
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  • Depuy Synthes Companies Of Johnson & Johnson
    Senior Quality Engineer
    Depuy Synthes Companies Of Johnson & Johnson Mar 2019 - Apr 2019
    Monument, Co
    -Serves as lead Quality Engineer for the Heading Blank Screw manufacturing processes-Responsible for initiating and investigating quality issues related to the Heading manufacturing processes-Contributes on global, cross-functional team responsible for new product launch-Owned NC and CAPA investigations, including risk assessment, root cause analysis and identified actions for closure-Responsible for tracking and reporting on site nonconformances for the site leadership team-Served as process improvement Deployment Lead. Duties consisted of facilitating Lean Training, managing 10 site-wide projects, communicating to site leadership and delivering high impact process improvements in manufacturing-Manages Summer Intern program for 2019, including writing job descriptions, coordinating interviews and tours, onboarding, and providing guidance for engineering interns
  • Depuy Synthes Companies
    Quality Engineer
    Depuy Synthes Companies May 2014 - Apr 2019
    Monument, Co
    - Owned NC and CAPA investigations, including risk assessment, root cause analysis and identified actions for closure, demonstrated proficiency in EtQ- Managed cross-functional JJOS project for identifying CTQ features for TFN and updating all documentation including PQP and Inspection sheets- Provided support during audits as document reviewer and scribe- Collaborated with multi-site team to identify opportunities for recall prevention- Tracked Field Action Investigations for North America to maintain accountability for timely completion of actions and Field Action Determinations- As Stop Shipment Coordinator, collaborated with global team to improve process efficiency to ensure only conforming product is available for distribution- Exceeded and maintained management goal of closing 75% of Aged Stop Shipments
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  • Depuy Synthes Companies
    Johnson & Johnson Operating Systems (Jjos) Deployment Lead
    Depuy Synthes Companies Jan 2018 - May 2018
    Monument, Co
    - Led cross-function teams and set goals/objectives with the deployment phase- Delivered on-boarding training to core team members- Completed Lean Fundamentals certification and led training modules within the phase- Maintained weekly communication of progress including CIP savings to with the Center of Excellence- Served as liaison between core team members and site leadership team to escalate issues and maintain communication
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  • Maetrics, Llc
    Compliance And Quality Consultant
    Maetrics, Llc Mar 2013 - May 2014
    Monument, Co
    Compliance and Quality Consultant – Quality Engineer: September 2013 – May 2014 Developed and implemented a process for performing Service History Reviews on all Service and Repair Complaints. Evaluated all devices returned to the Service and Repair department for inclusion in complaints in accordance with internal processes. Facilitated communication between Service and Repair department and Complaint department to align complaint handling process for repaired devices with global procedures. Trained the Service and Repair department on document revisions of complaint process.Compliance and Quality Consultant – Complaint Specialist II: March 2013 – September 2013  Assisted clients in complying with FDA Warning Letter requirements through process review, MedWatch submissions, and remediation efforts. Processed and verified complaints to bring the client into compliance with regulations. Collaborated with client to improve complaint handling processes and increase production.
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  • Baxter Healthcare
    Product Surveillance Quality Associate
    Baxter Healthcare Jul 2011 - Mar 2013
    Round Lake, Il
     Processed complaints and evaluated for adverse events, medical assessments, and FDA reportability. Mastered operation and characteristics of home renal dialysis and hemodialysis medical devices. Responsible for independent workflow management for processing complaints from initiation to closure and identifying issues requiring escalation. Increased quality of complaints as part of the Quality Review Board by reviewing work performed by other project members for accuracy.
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  • University Of Iowa
    Assistant To Lab Coordinator
    University Of Iowa May 2009 - Sep 2010
    Iowa City, Iowa Area
     Developed and improved laboratory procedures and manuals for undergrad physics courses. Handled and repaired mechanical and electrical lab equipment. Updated methods for organizing and tracking lab equipment locations throughout the building. Assembled circuit boards, read schematics, machined lab equipment and performed special projects.
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  • Archer Daniels Midland
    Refinery Intern
    Archer Daniels Midland May 2008 - Aug 2008
    Clinton, Iowa
     Developed method for enzyme storage and executed large scale trial in production environment. Organized mass balance equations for enzyme dosage into a database. Utilized Process Flow Diagrams and Piping and Instrumentation Diagrams to integrate enzyme into production.
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  • Archer Daniels Midland
    Research Intern
    Archer Daniels Midland May 2007 - Aug 2007
    Clinton, Iowa
     Conducted corn liquefaction experiment to optimize ethanol production. Wrote multiple Standard Operating Procedures for future use in the department.  Maintained a proper sterile work environment for fermentation process.
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Alexandra Wright Skills

Medical Devices Gmp Fda Iso 13485 Capa Microsoft Office Design Control Validation Quality System Technical Writing Software Documentation Quality Assurance Laboratory Iso 14971 Biomedical Engineering Hplc Biotechnology Analysis Corrective And Preventive Action U.s. Food And Drug Administration Cad Finite Element Analysis Matlab Biomechanics Engineering Product Development Leadership Root Cause Analysis Process Improvement Cross Functional Team Leadership Standard Operating Procedure Lean Manufacturing Quality Auditing Process Validation Quality System Regulation Continuous Improvement

Alexandra Wright Education Details

Frequently Asked Questions about Alexandra Wright

What company does Alexandra Wright work for?

Alexandra Wright works for Entegris

What is Alexandra Wright's role at the current company?

Alexandra Wright's current role is Quality Engineer at Entegris.

What is Alexandra Wright's email address?

Alexandra Wright's email address is al****@****ips.com

What is Alexandra Wright's direct phone number?

Alexandra Wright's direct phone number is +156324*****

What schools did Alexandra Wright attend?

Alexandra Wright attended University Of Iowa.

What skills is Alexandra Wright known for?

Alexandra Wright has skills like Medical Devices, Gmp, Fda, Iso 13485, Capa, Microsoft Office, Design Control, Validation, Quality System, Technical Writing, Software Documentation, Quality Assurance.

Who are Alexandra Wright's colleagues?

Alexandra Wright's colleagues are Jianan Hou, Amy Koland, Ryan Pautsch, Hideki Takahashi, Stacy Lee, Zahra Arafah, Jen Dolan.

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