Principal Quality Engineer - Jayuya, Puerto Rico - Baxter

Descripción

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Job Title: Principal Engineer (Critical System)

Department: Quality / Critical System

FLSA Status: SEE

Job Description:

Provides support, supervises, coordinates, implements, and develops all activities related to calibrations, environmental tests, sterilization qualification studies and critical systems in compliance with all legal and regulatory standards. Supervise the Sterilization area leading and performing technical duties at steam sterilization stations to achieve production schedule. Coordinate resources at the steam sterilization operation to mass-produce intravenous IV bags solutions products. Assure that all operations are in compliance with all Company standards.

Essential Duties and Responsibilities:

Supervises and provide technical support to all activities at the Critical Systems Area.

Maintain full compliance of critical systems area, calibrations and qualifications of steam sterilizers.

Approves and assure that all reports related to calibrations, steam sterilizers qualifications, critical systems and environmental test comply with internal procedures, policies and external regulations.

Fill out reports and the necessary documentation to comply with specifications and SOP's.

Prepare reports, such as monthly highlights, calibrations and steam sterilization cycles out of limit trends on a timely basis at a frequency required by the immediate supervisor.

Coordinates, schedules, assign and establishes goals at the Critical Systems Area.

Maintain full compliance with cGMP's and other Plant regulations (external and internal).

Perform internal audits to assure compliance with Local and Federal agencies.

Interview, hire and train Critical System Area personnel

Perform nonconformance investigations and implement corrective/preventive actions as required.

Review specification changes and comply with SAR systems requirements

Reviews Corporate policies changes, perform gap analysis and implementation and ensure that the Critical System area complies with requirements.

Initiates and implement changes to existing procedures or create new procedures related to calibrations, qualifications of steam sterilizers or critical systems.

Develop, modify, analyze and review protocols.

Assure continuity of department projects.

Develop and implement plans to reduce the Plant overhead costs for areas of responsibility.

Keep the working area clean and organized to comply with the 6S and lean concepts.

Perform any other task as required by immediate supervisor.

Teamwork oriented.

Willing to travel.

Should be able to handle many projects at the same time.

Willing to work extra hours, Holidays and at other shifts (eg. calibrate new equipment, shutdowns).

Supervisory Responsibilities :

Directly supervises 5 - 8 employees in the Critical Systems Area. Responsible for the overall direction, coordination, and evaluation of this unit. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications:

Education and/or Experience

Bachelor's degree (BS) in Engineering; three to five years related experience and/or training; equivalent combination of education and experience is a must. Knowledge in 21 CFR Part 211 and ISO 9001 current revision, highly desirable

Language Skills

Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, internal and external audits, and other departments. Fully bilingual (English and Spanish languages). Ability to communicate at all organization levels.

Mathematical Skills

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and take care of several abstract and concrete variables.

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