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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. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's 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 Baxter is seeking a dynamic and experienced Sr Principal Quality Engineer to lead quality activities and production support of the Carnation Ambulatory Monitor (CAM). The candidate will contribute to the successful qualification of new manufacturing processes, production line extensions, and design/process changes. The candidate will work closely with our local contract manufacturer to ensure timely resolution of product quality issues and oversee production lot release activities. In addition, the candidate will provide guidance on statistical methods, conduct risk management activities, and lead special projects to support the business. The ideal candidate will have extensive experience working in the medical device industry and a proven track record collaborating with internal and external teams. What you will be doing Provide Sustaining Quality Engineering support for commercialized products - directly responsible for production and process control activities. Provide production line support, including the review and approval of DHRs, NCMR/CAPA/Deviation initiation and resolution, and manufacturing process audits. Contribute to the qualification of manufacturing processes, equipment, new production lines, and process/design changes (change control). Support/lead the Supplier Quality management and purchasing controls process. Oversee qualification of new suppliers and surveillance of existing suppliers. Perform supplier audits of critical suppliers and contract manufacturers. Generate and provide guidance/feedback on quality records, including but not limited to design inputs/outputs, requirements, test plans, and test reports. Provide guidance on statistical methods and analysis for Design V&V, manufacturing process validation, and test method validation (attribute and variable). Conduct risk management activities: hazard analysis, risk analysis, identify and evaluate risk control measures, and health hazard evaluations. Lead special projects to support the business, as needed. Follow documented procedures for all activities related to the Bardy Dx Quality System. What do you bring Bachelor's degree in engineering or related scientific field. Minimum of eight (8) years of experience in a regulated quality assurance, quality engineering, and/or regulatory affairs position. Working knowledge of US and international medical device quality system regulations, including 21 CFR Part 820, MDD/MDR, ISO 13485:2016, and MDSAP. Working knowledge of medical device hardware and software development best practices. Strong interpersonal, verbal, and written communication skills. Organized self-starter, able to work in a fast-paced environment. Ability to work independently and as part of team; strong collaborative skills. Creative problem solver. Proficient in Microsoft Office, Adobe Acrobat, and statistical analysis software. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and c