Sr. Validation Engineer

• Nov 2020 - Present

Quality Engineer

• Jul 2020 - Nov 2020

Authored process and system validations Engaged in sustaining Quality activities (Change Order, NCR, CAPA, Risk Assessment) Provided review and feedback into engineering studies Authored process and system validations Engaged in sustaining Quality activities (Change Order, NCR, CAPA, Risk Assessment) Provided review and feedback into engineering studies

Sr. Quality Assurance Engineer

• Oct 2019 - May 2020

Review QMS and provide recommendations for compliance and improvement. Assist in implementation of audit response activities. Provide remediation for validation program databases and reference system. Revise Risk Management Files for IVD products and associated instrumentation. Review QMS and provide recommendations for compliance and improvement. Assist in implementation of audit response activities. Provide remediation for validation program databases and reference system. Revise Risk Management Files for IVD products and associated instrumentation.

Quality Engineer

• Sep 2018 - Oct 2019

Authored validations for IVD components in pre-market phase Supported Quality Sustaining Operations (logistics reporting, NCR investigation / implementation) Review of system and facilities validations Provide feedback and guidance for validation strategies Project Quality Lead for major change requests, ‘owned’ the Quality Plan / Plan Report for same. Authored validations for IVD components in pre-market phase Supported Quality Sustaining Operations (logistics reporting, NCR investigation / implementation) Review of system and facilities validations Provide feedback and guidance for validation strategies Project Quality Lead for major change requests, ‘owned’ the Quality Plan / Plan Report for same.

Quality Assurance Supervisor

• Jun 2017 - Oct 2018

Managed supervised Quality Inspection Staff in a fast paced contract manufactuing environment Enforced procedural requirements, provided training and guidance to staff Created and / or revised processes to ensure compliance. Drove company- wide improvements to process Managed supervised Quality Inspection Staff in a fast paced contract manufactuing environment Enforced procedural requirements, provided training and guidance to staff Created and / or revised processes to ensure compliance. Drove company- wide improvements to process

Quality Assurance Manager

• Mar 2016 - Jun 2017

Ensured regulatory requirements were captured and implemented within the QMS.Drove and managed all activities within the QMS (CAPA, NCMR, Validation, Complaints, etc)Served as point of contact (Management Representative) for all auditsReported performance of the Quality System to executive management.Gave / responsible for final approval of all phases of development for design projectsEstablished new manufacturing site through regulatory certificationManaged staff and resources within the Quality Department Show less

Compliance Specialist

• Jun 2015 - Mar 2016

Served as point of contact (Management Representative) for all audits Involved in all QMS activities (validations, CAPA, NCMR, staff training, complaints, inspections etc)Supported manufacturing / engineering departments with equipment and material solutionsEnsured Quality System compliance per ISO, MDD, and FDA regulationsPerformed supplier audits for vendors domestically and internationally.Initiated and directed new metrology and laboratory equipment purchasesAuthored and executed process and system validations Show less

Quality Associate

• Feb 2013 - Jun 2015

Involved in all QMS activities (validations, CAPA, NCMR, staff training, complaints, inspections etc)Supported manufacturing / engineering departments with equipment and material solutionsEnsured Quality System compliance per ISO, MDD, and FDA regulationsRepresented Quality during internal and external audits (FDA, foreign notified bodies)Performed supplier audits for vendors domestically and internationally.

Production Supervisor

• Oct 2012 - Feb 2013

Managed work flow and logistics of all production-related activitiesInterfaced with vendors and customers Supervised off-site production of products / components at CMO facilities Enforced quality standards in productionAuthored, edited, and implemented company procedures / processes,Provided task and process training to staff

Quality Assurance Lead

• Nov 2010 - Oct 2012

Supervised staff to ensure product quality from assembly inception to completionPerformed receiving, in-process and final QC inspectionsAssisted the engineering department with various research and development tasks.