Tech, QA Assurance at Baxter International in Aibonito, Aibonito, PR

Tech, QA Assurance Location: Aibonito, Puerto Rico 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. Your Team 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. What We Offer From Day 1 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 What You’ll Be Doing 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. What You’ll Bring: 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) SHIFT: Shift C (M-F from 20:00-6:00) and/or ShiftD (two weeks day 8hrs and Sat-Sun 12hrs) 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. Know Your Rights: Workplace Discrimination is Illegal 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 Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.