Medical Device Raw Materials

Chantel Tejeda

Phone: 978-***-****

E-mail: ******@*******.***

Objective

My goals are to utilize the skills mastered at my current position and perform at top talent level,

while helping others refine their skills. Procedures are important and order is my specialty, so I know that when it is time to gain new knowledge, they will come quick and I can help the team. advance. My hope is to continue to grow into a more competitive position. Overall, I love learning

new procedures and methods to add to my skill set, and love the industry I’m in..

Skills

Tech: All Internet Servers - Chrome, Email; Software: Microsoft Suite; Languages: English and Spanish

EDUCATION:

The Bilingual Institute, Paterson NJ, Certified in computer Operation 1990-1991

Certificate of Completion: EPTAC Corporation/IPC/WHMA-A--620

IPC-A-610, IPC-A-620, J-STD-001 AND IPC-771

WORK EXPERIENCE:

Access Vascular Billerica- MA, October 30, 2023 to Present

Medical Device Operator

DUTIES AND RESPONSIBILITIES

Manufacture, inspect and package products following written processes.

Work at a pace that meets established time standards while making quality product.

Identify quality issues or workmanship deficiencies related to equipment, assembly and inspection processes, materials, and manufacturing environment.

Comply with cGMP requirements by maintaining individual training records and adhering to documented manufacturing practices and procedures as defined in quality systems procedures.

Maintain a clean, safe and organized work environment.

Comply with all policies and procedures.

Perform other duties as assigned.

QUALIFICATIONS

Bristol Myers Squibb -May 1, 2023, to September

Bio process Associate

Operate production equipment within an assigned functional area adhering to Good Manufacturing Practices and standard operating procedures.

Revise and create process documents and assist with process related investigations.

Train for proficiency in process automation and supporting business systems and in the operation of primary production equipment within the assigned functional area.

Lead in maintaining material and components inventory level. Weigh and check raw materials.

Support a safe work environment and contribute to area specific initiatives associated with work safety.

Weighs and checks raw materials. Assembles, cleans and autoclaves process components. Assists in maintaining material and component inventory levels.

T2 Biosystems, Wilmington, MA October 2022-March 23

Reagent Manufacturing Associate I

● Formulation and filling of consumable products

● Perform assembly work of consumable products

● Assist with process improvement and capability analysis

● Perform weekly inventory

● Troubleshoot and resolve issues

● Follow established GMP and SOP

Conformis, Wilmington, MA, 2019- September 2022

Quality Inspector I, 1st Shift.

● Develop and maintain strong internal working relationships across Conformis and

understand the mission of the operations department.

● Reading blueprints and instructions to comprehend the quality expectations

The product and supplies

● Selection output samples and checking them using appropriate methods

transactions of workflow in ERP system

● Approving or rejecting raw materials with respect quality standards and record

Supplies performance

● Assist execution of preventive maintenance for equipment and materials

● Maintain records of testing, information and various metrics such as number of defective

Products per day.

● Comply with all company policies and procedures including safety regulations,

personal protective equipment requirements, Standard Operating Procedures, Work

Instructions, and Good Manufacturing Procedures

● Support engineering activities such as process validations and equipment

qualifications

DLH Corporation, Chelmsford, 9/2013 - May 2019

Shipper/Packer

● Work on one patient order at a time - confirming and refilling. Scan all prescription barcodes in an

order for packaging and inspect work after for compliance. Handle all confidential info.

Innopad Manufacturing, Wilmington, MA, 10/2012 -08/2013

Inspector

● Visual inspection of semiconductor polishing pad for quality control. Prep/test samples for research

and development; Laminating, die cutting and packaging pads for shipment.

● Collecting and inputting collected data into a Plexus system and/or Microsoft Excel.

● Efficiently maintaining an inventory of finished pads for future shipments, or testing.

● Floater with the ability to cover various jobs within the manufacturing process. Working in class

10,000 clean room environments.

Amphenol PCD, Beverly MA 05/ 2010- 09/2012

Cable Assembler

● Read instructions such as process details, diagrams, customer-supplier prints, etc. to determine

materials needed and sequence of assembly.

● Using approved hand tools and documentation, plug terminated wires into the appropriate

connector.

● Apply appropriate labels to wires, connectors, and/or cables.

● Inspect work during and after completion for compliance to documented standards ● In certain

cases, may test wiring continuity with continuity tester

Contact this candidate