Engineer, Quality Engineering

Job description

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. The Engineer, Quality Engineering has the following main responsibilities: · Qualification and Validation: o Support process developments and process changes to ensure that these are validated effectively in manufacturing by getting in depth knowledge of the processes and be a key role in PFMEA’s and their start up in manufacturing. o Support change controls/ design changes and to ensure that these are transferred in manufacturing with the right set up to prevent manufacturing issues or complaints from the market. This will be done by close review of validation protocols and methodology for transfer in manufacturing, be a key player in FMEA’s and risk assessment to ensure that the change will not cause adverse issues in our manufacturing and to our customers. o Perform validations as deemed necessary by her manager in relation to issues improvement actions and test methods in area of responsibility. o Lead/co-ordinate the plant’s master validation plan. o Support in data integrity requirements. · QC Duties and Responsibilities o The Engineer, Quality Engineering will lead/support test methods validation in the QC lab and ensure that these are done in a timely and compliant manner. She will support the Quality Manager in managing the lab and resolution of issues in the lab related to QC. o Ensure that all processes under responsibilities comply with customer and regulatory requirements and Baxter Quality Management Systems standards. · New equipment/ process in the lab: o To lead and validate new processes and equipment in the lab. · Process Improvement o The Engineer, Quality Engineering is also responsible for working closely with the Process Improvement Engineer to ensure that process issues are relayed back to the validation team to ensure that these are solved. General Duties and Responsibilities: The incumbent is to perform duties in accordance with procedures aligned with ISO13485. The incumbent is also responsible to ensure that all procedures related to her responsibilities are in line with TUV and Corporate requirements and that any corrective action triggered by TUV/ Corporate/ Internal/ Other audits are always implemented within the established time frames. The incumbent is also responsible to consider the aspects of Environment Health and Safety procedures to ensure that all the activities within her role will support EHS targets and will not jeopardize the health and safety of employees and environment. The incumbent must also ensure that all documentation and practices related to the role are in compliance with good laboratory and documentation practices. To support the Manager in other responsibilities as may be required. 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 employees, and we strive to be more transparent with our pay practices. The minimum salary for this position is €27 200 annually. Your initial pay could be at the minimum or higher based on skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. 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 .