Quality Technician

• Jan 2022 - Present

Quality Technician/Office Manager

• Aug 2020 - Sep 2021

Maintaining all activities under the responsibility of Acessa Inc. during the transition with a focus on document support. Office Security to include remote connection. • Effectively manage Quality Technician functions, specifically in the areas of Inspection and Document Control, Training, and Return Material Management. • Participate in regulatory audits from Notified Body as subject matter expert for multiple sections related to Quality Technician responsibilities. • Manage facility by invoicing payments and general maintenance. • Maintain Office Management tasks including office and breakroom supply, conference room schedule and team building events using strong organizational skills. • Use Oracle for receiving activities and use Agile for tracking, as Change Analyst. • Create labels, track, schedule and log information to manage shipment. • Collaborates with vendors by building strong relationships. • Provide document training for effective onboarding. Show less

Quality Technician/Document Control Specialist

• Jan 2019 - Sep 2021

Document Control Activities: Creating, completing, documenting, revising documents, tracking, and releasing Change Orders. Maintaining both electronic and hard copy files. Evaluate and develop improved techniques for Quality controlled documents. Assisted in internal/external audits. • Maintains files on location in an orderly fashion, to easily facility recovery. • Coordinates Change Order, RMA, Inspection, Receiving, Shipping, Training, Document Master Index, Approved Supplier Maintenance to ensure current certification. • Issued and tracked RMA’s, processing receipts for complaint processing as RMA Coordinator. • Recorded training as Training Coordinator to comply with regulations, policies and procedures. • Inspected incoming product to finished goods by creating improved inspection process. • Documented review of all DHR’s from inspections to include vendor communication. Paula Gelinas 512-318-8802 Page Two • Provided Root Cause Analysis (RCA) to investigate issues to assist in CAPA, SCAR and PAR. • Reported on Quality Document activity during management review. • Created and maintained electronic/hard copy files onsite and offsite for easy recovery. • Complied with regulatory ISO 13485 – FDA regulations to minimize business risk. Show less

Driver

• Jul 2017 - Aug 2020

Uber is more than just a connection of point A to point B. Customer Service of requested trips is a priority., making their trip an enjoyable experience. Uber is more than just a connection of point A to point B. Customer Service of requested trips is a priority., making their trip an enjoyable experience.

QC Technician

• Feb 2016 - May 2018

Verified paperwork for all production releases and product shipments and communicated with internal and external customers. Generated and maintained all site training records. ISO 9001. • Trained on corporate and site document control procedures and policies for effective onboarding. • Conducted inspections for Root Cause Analysis and the completion of NCMR/DCR, CAR/PAR. • Performed Site Internal Quality Audits per ISO 9001. • Created production work instructions to align with customer requirements. • Performed document control of revision, distribution, obsolescence, of all site documents • Maintained vendor database per corporate excel scorecards. Show less

Administrative Quality Assurance; ISO Lead Auditor

• Nov 2014 - Feb 2016

•Managed incoming and outgoing correspondence. between Customer and Manufacturer •Inspected and analyzed product, and packaging for Root Cause analysis determination. •Created and maintained all records for material inventory for inspection and/or RTV/MRB requirements •Created 8D reports on Customer Complaints when required •Warehouse Management of Non-Conforming/Quarantined Material •Analyzed processes to identify areas for improvement for Warehouse Quality issues. •Managed incoming and outgoing correspondence. between Customer and Manufacturer •Inspected and analyzed product, and packaging for Root Cause analysis determination. •Created and maintained all records for material inventory for inspection and/or RTV/MRB requirements •Created 8D reports on Customer Complaints when required •Warehouse Management of Non-Conforming/Quarantined Material •Analyzed processes to identify areas for improvement for Warehouse Quality issues.

MRB Coordinator

• Apr 2013 - Nov 2014

•SME in all inventory and inspection programs •Training on test processes and inspection software. •Responsible for maintaining directional movement to reduce inventory of MRB material. •Created and maintained all records for material inventory for inspection and/or RTV/MRB requirements •Performed root cause analysis and corrective action procedures •Maintained stock par levels of supplies needed for production requirements •Conducted departmental material transfers to meet production needs. Show less