Quality Engineer

Baxter International Inc.; Puerto Rico; On-site; USD 55,000 - 75,000; Full time

Job summary

Baxter International Inc. in Aibonito, Puerto Rico seeks a Quality Engineer I to ensure compliance with Quality System regulations and support process control. You will provide technical expertise and participate in protocol development, investigations, and continuous improvement initiatives.

The role requires collaboration across functions, knowledge of GMP/ISO, and ability to work with cross-functional teams to meet regulatory requirements and product quality goals.

Qualifications

• Bachelor's degree in Engineering; at least 1 year experience and statistics knowledge.
• Strong knowledge of GMP, FDA, ISO requirements and quality systems.
• Ability to perform root cause investigations and support continuous improvement.

Responsibilities

• Provide quality guidance for process/area responsibilities and perform risk assessments.
• Participate in process validation and equipment/subassembly protocols.
• Contribute to software validation and data integrity of applications.
• Lead investigations into non-conformances and implement CAPA.
• Prepare Quality Data Reviews monthly and quarterly.

Skills

Quality engineering

Root cause analysis

GMP knowledge

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

Outlook

TrackWise

TcU

Job description

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

- Descripción de Puesto (Job Description)

TITULO PRINCIPAL DEL PUESTO (MASTER JOB TITLE):

ENGINEER I

TITULO FUNCIONAL DEL PUESTO (FUNTIONAL JOB TITLE):

QUALITY ENGINEER I

LOCALIDAD (LOCATION):

AIBONITO

DIVISION:

HOSPITAL PRODUCTS

SE REPORTA A (REPORT TO):

QA MANAGER

FECHA DE EFECTIVIDAD (EFFECTIVITY DATE):

AUGUST 2019

RESUMEN GENERAL (SUMMARY):

Incumbent will be responsible for insuring compliance with the Quality System Regulation regarding Quality and Manufacturing Processes and methods. In order to perform effectively the incumbent must be knowledgeable of all processes, product specifications and quality functions. Provide the Aibonito facility with technical support to assure process control. Provide support and service to their respective areas. Responsible to ensure their responsibility areas are in compliance with internal and external regulations. Capable of supervising and or following instructions effectively and in timely manner. Provide the Aibonito facility with technical statistical support to assure process control. Participate in protocols, first of codes, Non-compliances and exceptions evaluation, changes of specs. SOP’s, special tests and /or projects.

TAREAS Y RESPONSABILIDADES (DUTIES AND RESPONSIBILITIES):

• Responsible for compliance and providing Quality guidance for process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Leads and conducts root cause investigations for multi-group projects in the development of continuous improvement and corrective / preventative action philosophies and strategies. Support the Aibonito facility with technical knowledge, modification specifications and procedures, special tests and /or projects.
• Participate and maintain full knowledge of the Quality Operations.
• Participates in the process validation and protocols of equipment and/or subassemblies.
• Participates in the Software Validations and Protocols of equipment and/or database applications.
• Participate in the Quality Programs.
• Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
• Able to review documentation in compliance with GMP and GDP.
• Support the design, development enhancement of product processes and technologies modifications.
• Evaluation of customer complaints.
• Conduct Non-conformance Investigations and be able to approve as quality representative.
• Develop and evaluate Quality Sampling Plans techniques for further improvement.
• Responsible for the Continuous Process Verification (CPV) program
• Any special project as assigned.
• Observes all company and regulatory EHS requirements.
• Prepare Quality Data Review on a monthly and quarterly basis.
• Participate in internal and external audits
• In charge of the analysis of Defect per Million (DPM) per defect/ product in a monthly basis
• Lead assigned programs (e.g. Sterilization, Parametric Release, etc.) from the quality standpoint to assure compliance. Review and approve related documentation.
• Evaluate sterilization alarms and provide final disposition to product based on procedures and specifications.
• Provide feedback and support to steam sterilization projects as subject matter expert.
• Must perform any work necessary to avoid the delay in the release of the product.
• Knowledge in Computer Programs (e.g. Microsoft Office, Outlook, Trackwise, TcU).
• Coordinate, participate and perform meetings with multidisciplinary teams as required.
• Prepare reports for management review and quality data indicators as required.
• Team worked oriented.
• Able to work under minimum supervision and to handle multiple tasks at the same time.
• Should be able to comply with the established projects goals and schedule milestones.
• Must be able to communicate effectively at any plant level.

DEMANDA FISICA (PHYSICAL DEMANDS):

Light Work : Exerting up to 20 pounds of force occasionally and/or a 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Physical demands requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible.

EDUCACIÓN Y/O EXPERIENCIA (EDUCATION AND/OR EXPERIENCE):

Bachelors Degree in Engineering. At least one-year experience and statistical applications knowledge.

CUALIFICACIONES (QUALIFICATIONS):

Uses engineering and management practices/knowledge, statistical methods, computer systems and technical reporting. A self-starter capable of maintaining full understanding and up to the moment information of the Quality day-to-day activities. An individual with the ability of interacting with personnel from all levels, capable of supervising and or following instructions effectively and in timely manner. Must be willing to travel occasionally.

IDIOMA (LANGUAGE):

Fully bilingual (English & Spanish).

DECLARACION DE NEGACION (DISCLAIMER STATEMENT)

Las declaraciones mencionadas anteriormente describen la naturaleza general y el nivel de trabajo que se les requiere a los empleados a quienes se les asigna esta clasificación. No pretende constituir una lista exhaustiva de las responsabilidades, tareas y destrezas requeridas para el personal así clasificado.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

US Benefits at Baxter (except for Puerto Rico)

• This is where your well-being matters.
• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.
• Join us and enjoy the competitive compensation and benefits we offer to our employees.
• For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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