Baxter
Baxter is looking for a Senior Quality Engineer #EngineerJobs
This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxters products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives” where your purpose accelerates our mission. Your role at Baxter: 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 Manufacturing Engineering 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, software, 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 order to generate proactive and timely actions when needed to address a quality issue or improve a process. Assure product compliance to specifications through implementation of inspection criteria and procedures in operations 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. 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 Baxters internal guidelines. 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 validation, data integrity, risk management and other applicable regulations. Other duties as assigned. What you’ll bring: Minimum of a Bachelor of Science in Engineering is required 3 to 5 years related experience or demonstrated performance within Quality or Manufacturing Engineering. Masters 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. * Demonstrated experienced on process validation and risk management for medical device manufacturing. 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. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $60,000 to $132,000, plus an annual incentive bonus. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law. 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 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 . 098606
Baxter