Jessica W. Email & Phone Number

Yuma, Arizona, United States

• Advanced from Laboratory Technician to Quality Assurance Coordinator, then to Quality Department Lead, and currently serving as Interim Supervisor of Quality. • Maintain a working knowledge of government and industry quality assurance codes & standards. • Recommend new policies or modifications to existing policies & Standard Operating Procedures (SOPs). • Monitor CAPA's and their effectiveness checks to ensure that all issues have been resolved.• Participate in audits and implement corrective actions to ensure compliance with company policies & regulations. • Create & manage deviation documentation by assigning roles & responsibilities to ensure timely investigation and resolution. • Train new employees, as well as monitoring all quality employee performance. • Act as a liaison with the divisions, suppliers, manufacturing, and operations to ensure quality of products & customer satisfaction. • Actively participate in the Safety Program and Employee Resource Groups. • Assist in testing, inspection, validations, and re-work of product. • Perform sampling inspections following the Acceptable Quality Limit (AQL) method, adhering to the ISO 2859 standard and its equivalents in national regulations.• Experienced and familiar with ISO 13485, ISO 9001, ISO 14971, ISO 11135, and ISO 13408.• Release products for shipping via the SAP Easy Access program and file any quality documentation required. • Use pallet jack & forklift to pull, stack, and prepare pallets for shipping. • Properly dispose of any hazardous medical products that did not pass quality inspection or sterilization parameters.

Yuma, Arizona, United States

•Lead the establishment and maintenance of efficient workflow and prioritization for Quality Control projects at Medline distribution center. •Ensure compliance with established quality and reliability standards and provides support to Operations and QC Supervisor when needed.•Serve as backup to QC Supervisor as needed; including interfacing with distribution center quality personnel from multiple sites within reporting region.•Contribute to corporate functions such as workload distribution across regions and project tracking.•Prioritize, coordinate, and perform all recall stock checks and reworks, providing expedited communication and completed reports to Recall Department.•Complete hold and release of products as advised.•Prioritize and perform stock checks, including AQL specified inspection parameters when included, and report results via designated forms to divisional partners.•Prioritize and perform reworks and provide detailed reports to divisional partners.•Coordinate project/rework area, required supplies, and labor resources including Operations and Temporary labor services.•Maintain daily report of all held stock using SAP and Excel.•Communicate with divisional partners to resolve hold issues and complete releases as authorized.•Operate material handling equipment as necessary to complete held stock tagging, pull and replace products for reworks, stock checks, and inspections.•Use computer systems daily for regular communication, generating and contributing to reports, investigating product related information, and tracking all project time.•Evaluate product integrity and provide disposition for damaged Freights Claim product to •Transportation and Inventory teams; provide information about condition and ability to salvage.•Direct work responsibilities of distribution center quality personnel (all levels on-site). •Oversee and advise on-site quality personnel to ensure proper workflow and project completion.

Yuma, Arizona, United States

•Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.•Act as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.•Manage complaints and develop new approaches to solve problems identified during the investigation process.•Identify and manage the execution of continuous improvement projects. •Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint.•Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.•Ensure all quality issues are resolved to customer satisfaction, in a timely manner.•Resolve issues relating to product or production quality by interfacing with internal and external customers.

Yuma, Arizona, United States

•Review and audit the data and records generated by the sterilization department•Ensure any batch record errors are corrected, all batch record components are present, and exception documents are referenced and approved•Ensure Quality goals are met, and all practices and procedures comply with Company policies and applicable regulations•Communicate batch release progress or delays to quality and materials management•Packaging Operations: Ensure all in-process and release testing is complete and all Quality holds are released•Release batch records in electronic systems according to global, local, customer, and regulatory requirements•Interface with various electronic databases/systems to interpret data pertinent for release to specific departments •Interact with other departments, external customers, and regulatory agencies to ensure batch records are retained and filed securely•Lead problem-solving activities and coordinate the implementation of identified solutions•Handle Biological Indicator positive controls and Limulus Amoebocyte Lysate samples for testing.•Use air purifier clean bench for medical devices that require special handling.

Yuma, Arizona, United States

•Review and audit the data and records generated by the sterilization department•Ensure any batch record errors are corrected, all batch record components are present, and exception documents are referenced and approved•Ensure Quality goals are met, and all practices and procedures comply with Company policies and applicable regulations•Communicate batch release progress or delays to quality and materials management•Packaging Operations: Ensure all in-process and release testing is complete and all Quality holds are released•Release batch records in electronic systems according to global, local, customer, and regulatory requirements•Interface with various electronic databases/systems to interpret data pertinent for release to specific departments •Interact with other departments, external customers, and regulatory agencies to ensure batch records are retained and filed securely•Lead problem-solving activities and coordinate the implementation of identified solutions•Handle Biological Indicator positive controls and Limulus Amoebocyte Lysate samples for testing.•Use air purifier clean bench for medical devices that require special handling.• Transitioned from Centurion Medical Products to Medline Industries after company procurement.

Respond to inbound calls from customers, dealers, and insurance agents regarding vehicle loans.Communicate in a professional and service-oriented manner with Spanish and English-speaking customers.Accurately and timely handle all aspects of customer inquiries, account maintenance, and transactions.

Respond to inbound calls from customers, lawyers, hospital representatives, and vehicle repair shops in order to process claims.Process home claims for situations such as losses due to theft, fire, and flooding.Set up appointments with customers to have vehicle inspected for damage.

Train staff on products and services offered by Arizona Public Service (APS) in order to have them provide excellent customer service.Perform interviews in person and over the phone to select candidates that would be a positive asset to the company.Handle inbound calls for APS customers to answer any utility questions they may have.Determine charges for services requested, collect deposits and/or payments, as well as arranging billing services.Obtain and examine all relevant information from the customer to determine possible causes for higher utility bill and provide a resolution.

Master Of Business Administration - Mba, Business

Activities and Societies: Dean's List, Honor Society Member, and scholarship recipient.

Bachelor'S Degree, Human Resource Management Certificate

Activities and Societies: Dean's List, Honor Society Member, and scholarship recipient.

Bachelor Of Science, Business Administration And Management, General

Activities and Societies: Dean's List, Honor Society Member, and scholarship recipient.

Associate'S Degree, Business

High School Diploma