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 Role
This position provides Quality Engineering support to one or more product lines at the Irvine facility. The Quality Engineer will support the manufacturing operation from raw materials to finished device, maintain the Risk Management process and related documentation, and closely interact with product design and vigilance functions to address quality issues and facilitate continuous improvement of product quality.
The position supports the sustaining of production processes in a state of control and compliance through the planning, execution and implementation of process validation and controls to meet regulatory agency validation requirements, internal company standards and current industry practices. Authors and reviews validation processes and procedures, making recommendations for changes and/or improvements. Position may focus on equipment, process or control system validation or a combination there of.
What You'll Be Doing
·Evaluate all relevant operational data, reports, statistics and documentation related to manufacturing process and product performance in the field, in order to generate proactive and timely actions when needed to reduce CIPM.
Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes. Drives quality and manufacturing improvements to ensure our processes are in state of control.
Develop and analyze statistical data and product specifications to ensure product quality.
Apply standard operating practices and problem-solving methodology.
Perform root cause investigation analysis and prepare reports, for negative trends of process or product failures or critical characteristics not being met. Document such actions within the quality system as appropriate (NCR/CAPA).
Organize, review and perform computer system validation or other software validation related evaluations to support the Master Validation Plan. Support the data integrity initiatives to relevant systems, processes and equipment.
Develop and maintain Risk Management Documentation including software risk for all product families or software defects.
Perform validation activities as assigned (DQ, IQ, OQ, PQ, TMV, etc.).
Partner with Project and Manufacturing Engineering to ensure the smooth transition of projects into day-to-day operations and software changes.
Evaluate and/or perform computer system validation for applicable software or GxP computerized systems per Baxter.
Analyze and perform assessments for software change controls for computer system validation, data integrity, hardware interactions and cyber security impact.
Provides coaching and mentoring to the organization regarding CSV, SDLC, data integrity and cyber security standards, regulations, guidance, and best practices.
Other duties as assigned.
What You'll Bring
Demonstrated experienced on process validation and risk management for medical device.
Engineering depth and ability to understand product and process operating principles, control points and methods, design and process interactions and end user impact.
Must have strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.
Must be able to update procedures and modify processes to simplify complexity and improve efficiencies.
Education and/or Experience
Minimum of a BA or BS in Engineering having a minimum of 3 to 5 years related experience or demonstrated performance within Quality Engineering.
A Master’s degree can be used in lieu of 2 years of related experience. Engineering or Business Administration major is preferred.
Lean or Six Sigma Green Belt or higher is preferred.
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.
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
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