Senior Quality Assurance Engineer

13 hours ago


Deerfield Beach, Florida, United States Baxter Full time
About the Role

We are seeking a highly skilled Senior Quality Engineer to join our team at Baxter. As a Senior Quality Engineer, you will play a critical role in supporting the development of new products and on-market products used in surgical procedures.

Key Responsibilities
  • Apply innovative techniques in the area of expertise to support the development of new or improved products
  • Support the sustainability and life cycle management of existing products
  • Ensure compliance with global quality systems and Regulatory requirements related to product and process
  • Provide Quality Assurance support and mentorship for verification and validation of product requirements
  • Perform design change control activities including impact assessments, reviews, and approvals
  • Take lead role in CAPA activities such as investigation, implementation, or verification of efficiency
  • Support risk management activities as they relate to product and post market surveillance
  • Interact with on-shore and off-shore suppliers to complete project related activities
Requirements
  • B.S. degree in Engineering with at least 3-5 years of experience working in a regulated environment
  • Higher degrees desired with proven experience in medical device industry
  • Proven success in delivering results on several technical challenges
  • Solid understanding of medical device international standards
  • Must have experience working with all classes of Medical devices preferably implantables, Biologics, and/or combination products with sophisticated training and show strength in problem solving, total quality management, DHF remediation, Risk file remediation, EUMDR, problem analysis and resolution, and design of experiments
  • Experience with New product development activities as R&D lead or QE lead in various product development teams
  • Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls
  • Extensive multi-functional team experience, including technical and non-technical work
  • Strong interpersonal, communication, influencing, and negotiation skills
About Baxter

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is a meaningful 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 estimated base salary for this position is $88,000 - $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time



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