Senior Principal Quality Engineer
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. The Senior Principal Quality Engineer will work as a member of one or more project teams by being engaged in new product development and/ or sustaining products activities related to medical devices, independently representing the Quality function and ensuring that each project is developed and released meeting customer expectations and regulatory requirements. Essential Duties and Responsibilities Work closely with product engineering in generating Design Plans and reviewing design inputs, outputs, verification, validation and design transfer strategies, including risk management. Provide support to product sustaining engineering specifically through risk and change control management. Provide support to post market activities such as complaint investigations, complaint trending, CAPA and FA processes as necessary. Provide quality input to DHF and risk remediation activities. Preside as subject matter expert (SME) and be a key participant in compliance audits and FDA/Ministry of Health inquires. Provide training / guidance to project personnel regarding the appropriate application of design, statistical and analytical tools. Prepare and Lead monthly Quality data reviews Assist in decision making for process improvement efforts. Mentor others in the areas of Quality Engineering and Quality System regulations. Education and Experience B.S Degree in engineering Requires 10
years of experience in Quality, Manufacturing, Engineering in Medical Device industry. Cross-industry experience a plus. (e.g., automotive, aerospace, combination products) Medical Device regulatory experience preferred. (FDA, EU MDR, etc) Excel proficiency required
Salary Range:
$100K -- $150K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
years of experience in Quality, Manufacturing, Engineering in Medical Device industry. Cross-industry experience a plus. (e.g., automotive, aerospace, combination products) Medical Device regulatory experience preferred. (FDA, EU MDR, etc) Excel proficiency required
Salary Range:
$100K -- $150K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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