Senior Design Quality Engineer

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. Senior Design Quality Engineer will be responsible for providing technical support and service for all aspects of quality engineering while ensuring compliance with safety standards and global regulatory requirements. Design Quality Engineer applies a solid understanding of theories/practices applied by other fields outside the primary area of expertise toward the development of new or enhanced products or Quality processes. The person in this role plans, implements and functionally advises important engineering assignments, which require independent judgment. What you’ll be doing Apply innovative techniques and expertise to develop new or improve products and processes Lead several moderate projects for multiple products Independently plans, schedules and leads cross-functional team in detailed phases of the Quality work in a project Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and/or complaint reduction Lead audit ready status efforts for assigned areas and assist other areas in understanding FDA, ISO and Baxter quality requirements Take lead role in NCR/CAPA activities such as investigation, implementation, or verification of effectiveness Support risk management activities as they relate to product and post market surveillance Provide product quality support on new product development, risk management, design transfer and sustaining engineering Work collaboratively with R&D to develop Product Design Requirement and & Test Methods for successful Design Verification and Validation Defend/support product design history file (DHF) in internal and external audits · What you'll bring Bachelor’s degree in engineering and minimum three years’ experience in Quality, Manufacturing, and/or Engineering in the Medical Device and/or Biologics/Therapeutics field Product development experience with medical devices preferred Proficient in relevant products or process development processes (i.e. NPD and sustaining-life cycle management) Must have experience with Design History File (DHF) and Risk Management File (RMF) Demonstrate leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Design Change controls Good project management skills Ability to coordinate and present technical and project mgt. overviews without assistance Solid understanding of FDA Regulations (e.g. 21 CFR Part 820), Application of Good Laboratory Practices, Application of Good Manufacturing Practices, ISO (e.g. ISO13485 and ISO14971) and other applicable standards (e.g. IEC60601 and IEC62304 electromechanical medical device) and regulatory requirements (e.g., EU MDD and MDR) This role gives you the scope of a global healthcare organisation while keeping your contribution close to the work, customers and products it supports. If the Senior Design Quality Engineer role matches your experience and the kind of responsibility you are looking for, we’d like to hear from you 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 €32.000 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 .