Tech, QA Assurance

Baxter International Inc. • Aibonito, PR

10d • 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. You will be part of a highly skilled Quality organization dedicated to maintaining the highest standards in medical device manufacturing. Our team thrives in a collaborative, fast‑paced environment where attention to detail and proactive problem solving are essential. When you join us, you will collaborate with engaged professionals who value knowledge sharing, mentorship, and continuous development—while keeping patient safety at the center of everything we do.

Requirements

• Bachelor’s Degree in Science or related field.
• Minimum of two (2) years of Quality experience within the Medical Device industry.
• Experience using measurement and inspection instrumentation.
• Strong analytical, auditing, and documentation skills.
• Effective interpersonal and communication skills.
• Bilingual (English & Spanish)

Responsibilities

• Ensure compliance with Quality System Regulations related to manufacturing processes, methods, and quality functions.
• Review and approve quality documentation, including In‑Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records, and related records.
• Conduct routine manufacturing audits of machine parameters, setups, and finished product to ensure compliance with specifications and procedures.
• Audit sampling techniques, testing skills, and documentation executed by TIQs.
• Provide immediate notification and escalation to Quality Management regarding potential quality issues or risks.
• Assist and coordinate quality and manufacturing protocols, including validation and improvement initiatives.
• Provide training on Good Documentation Practices (GDP), Statistical Process Control (SPC), Total Integrated Quality, and related quality tools.
• Support mold approval activities and mold startup evaluations, when applicable.
• Gather, analyze, audit, and interpret data using SPC tools to identify trends and recommend process improvements that reduce scrap, DPMs, complaints, and cost of non‑conformance.
• Maintain, review, audit, and calculate control chart limits as required.
• Ensure all machinery, equipment, tools, and measuring devices comply with Corporate, GMP, and regulatory requirements.
• Publish monthly Quality Indicators, including DPMs and Pareto analyses for assigned areas.
• Propose and submit improvements or modifications to specifications and Standard Operating Procedures.
• Maintain timely communication with internal and external customers/suppliers regarding quality trends, complaints, and DPM performance, as applicable.
• Assist in the development and certification of TIQs.
• Participate in and lead special projects related to assigned quality responsibility areas.
• Manually and electronically document required process and production information (e.g., checker charts, POMs) per procedures and specifications.
• Conduct EHS inspections to identify safety hazards and environmental aspects; analyze incidents and near misses and implement corrective actions.
• Support software application audit execution.
• Assist in the generation, investigation, and resolution of non‑conformances.
• Observe data privacy and confidentiality policies at all times.

Benefits

• Medical, Dental, Disability, and Life Insurance Coverage
• Vision Plan
• Paid Vacation Days and Paid Holidays
• Paid Parental Leave
• Retirement Plan
• Employee Stock Purchase Program
• Educational Assistance Plan
• Comprehensive compensation and benefits packages
• Health and well-being 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
• 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
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits

What This Job Offers

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