

New · posted Nov 12
Baxter · Medical Devices
Tech, QA Assurance - Shift C (Week Nights)
- Aibonito, PR
- On-site
- Full-time
- Associate & Specialist
The role
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.
Work shift: Shift C (Week Nights)
Your role at Baxter:
As a Quality Technician, you will play a pivotal role in ensuring that our manufacturing processes and methods meet the highest standards of quality and compliance. Your expertise will be essential in maintaining the integrity of our Quality System Regulation, ensuring that every product we produce is detailed and meets our outstanding standards.
Beneficios y Horario de Trabajo
- Horario: Disponibilidad completa para trabajar en el turno nocturno durante la semana. 10:00pm - 6:30am Lunes a Viernes
- Diferencial por turno
- Vacaciones y días feriados pagados
- Cobertura de seguro médico, dental, por incapacidad y de vida
- Seguro de visión y beneficios voluntarios (Desde el dia 1)
- Licencia Maternidad y Paternidad remunerada
- Plan de ahorro para el retiro 165e
- Programa de compra de acciones para empleados
- Plan de asistencia educativa
Your team:
Baxter prioritizes the development of high-quality products that address patient needs. Our team is dedicated to putting patients first and takes pride in the value we deliver. Joining our multinational organization offers the opportunity to collaborate with diverse individuals, explore different areas of our portfolio, and receive ongoing support from our leadership team for personal growth.
What you'll be doing:
- Revise and approve all documentation related to areas of responsibility, including In Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records, and more.
- Conduct routine manufacturing audits of machine parameters and set-ups to ensure compliance, as well as audits of the manufactured product.
- Perform routine audits of sampling techniques, testing skills, and all documentation performed by the TIQ's.
- Immediately notify and raise awareness to Quality Management about potential quality situations.
- Assist and coordinate protocols to ensure detailed execution.
- Provide training on Good Documentation Practices, SPC, Total Coordinated Quality, and other relevant areas.
- Support mold approval and mold start-up evaluations, if applicable.
- Gather, analyze, audit, and interpret data using SPC methods to predict trends and recommend process improvements that positively impact product quality, scrap reduction, DPM reduction, complaints reduction, and price of non-conformance reduction.
- Maintain, revise, and audit control charts, computing control chart limits as needed.
- Ensure that all machinery, equipment, tools, and supervisory materials align with Corporate, GMP, and other regulatory requirements.
- Publish monthly Quality Indicators, including DPM's and Pareto Analysis, within your areas of responsibility.
- Submit improvements and modifications to specifications and Standard Operating Procedures.
- Maintain timely communication and awareness of DPM and complaints trends with internal and external customers/suppliers, if applicable.
- Assist in the development and certification of TIQ's.
- Perform special projects related to your areas of responsibility.
- Document required information manually (e.g., checker charts) and electronically (e.g., POMs) to align with applicable procedures and specifications.
- Conduct EHS inspections to identify and mitigate safety hazards and environmental aspects, analyze EHS incidents, and take corrective actions.
- Observe data privacy policies at all times.
- Provide support for software application audits.
- Assist in the generation and investigation of non-conformities.
What you'll bring:
- Bachelor's degree in Science.
- At least two years of related job experience in the Medical Device Industry.
- Proficiency in Data Entry and Microsoft Office Software, with basic computer knowledge required.
- Experience with measurement instrumentation.
- Excellent interpersonal skills.
- Willingness to travel occasionally.
- Bilingual (English & Spanish).
What you need
Pay
Baxter didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
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
Where you'll work
Aibonito, PROn-siteOpen in Maps (opens in a new tab)
More jobs in Aibonito, PREqual opportunity, accessibility and legal noticesBaxter's statements, word for word
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
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.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $79,250 | $86,000 | $96,750 |
Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 108 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Baxter's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 46 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Documentation and SOPs5
- Collaboration and leadership5
- Lab testing and methods4
- Investigations and CAPA3
- Quality systems and risk3
- Data and digital systems2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
Company hiring pulse
Baxter on Regulatory Jobs
- 56
- Open roles
- 56
- Distinct roles
- 12
- Locations
By discipline
- Quality52 91%
- Regulatory5 9%
By level
- Associate & Specialist26 46%
- Senior & Principal14 25%
- Manager9 16%
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Tech, QA Assurance - Shift C (Week Nights) at Baxter
Open until filled.


