Quality Technician (Shift C)

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. 

Incumbent will be responsible for insuring compliance with the Quality System Regulation regarding quality and manufacturing processes and methods.  In order to perform effectively the incumbent must be knowledgeable of all processes, product, specifications and quality functions.

TAREAS Y RESPONSABILIDADES (DUTIES AND RESPONSABILITIES):

1. Revise and approve all documentation related to the areas of responsibilities such as:In Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records related and others.

2.  Responsible for routine manufacturing audits of machine parameter and/or set-ups for compliance as well as the product manufactured.

3.  Perform routine audits of sampling techniques testing skills ­­­­and all documentation performed by the TIQ's.

4.  Responsible for an immediate notification and awareness to Quality Management of potential Quality situations.

5.  Assist and coordinate protocols.

6.  Provide training as required on:  Good Documentation Practices, SPC, Total Integrated Quality and others.

7.  Provide support regarding mold approval and mold start up evaluations  (if applied).

8.  Gather, analyze, audit and interpret data using SPC methods so as to be able to predict trends and recommend process improvements that would impact favorably on product quality, scrap reduction, DPM reduction, Complaints reduction, price of non-conformance reduction and others. Maintains, revise and audits control chart and compute control chart limits as required.

9.  Insure that all machinery, equipment, tools or any other measuring, monitoring material complies with Corporate, GMP and other regulatory requirements.

10.  On a monthly basis publish Quality Indicators including DPM’s, Pareto Analysis on responsibility areas.

11.  Submit improvements and/or modifications to specifications and Standard Operating Procedures.

12.  Maintain good timely communication and awareness on DPM and complaints trends with the internal and external customers/suppliers. (if apply)

13.  Assist in the development / certification of the TIQ’s.

14. Perform special projects related to responsibility areas.

 15. Manually document (ex: checker chart) and/or electronically (ex: POMs) the required information to comply applicable procedures and specifications. This information includes but is not limited tp process parameters, lots, amount of production, and others.

16.  Observes all company and regulatory EHS requirements.

17.  Observe data privacy policies at all time.

18.  Provide support on Software application audits execution.

19.  Assist on the generation and investigation of non-conformities

EDUCACIÓN Y/O EXPERIENCIA (EDUCATION AND/OR EXPERIENCE):

Bachelor Degree Science. 

At least two years of experience dealing with related job on Medical Device Industry.

CUALIFICACIONES (QUALIFICATIONS):

Knowledge in Data Entry – Microsoft Office Software. Basic computer knowledge is required Experience in measurements instrumentation. Good interpersonal skills.  Willing to travel occasionally.

IDIOMA (LANGUAGE):

English & Spanish

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

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