Quality Engineer - Process

Baxter International Inc. • Aibonito, PR

1d • Onsite

About The Position

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.

Requirements

• Bachelor's degree in engineering.
• At least one-year experience and statistical applications knowledge.
• 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.
• Fully bilingual (English & Spanish).

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.

Benefits

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• paid holidays
• paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level