Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.
Summary of the role
As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.
Summary
The Senior Quality Engineer is responsible for maintaining and improving the Quality Management System (QMS) across the product lifecycle-from design and development to manufacturing and post-production. This role leads CAPA and risk assessment activities, supports supplier quality programs, manages engineering projects, and ensures compliance with regulatory standards through audits and validations.
Key Responsibilities
* Lead CAPA investigations and risk assessments for new and existing products.
* Demonstrates strong project management skills by effectively leading CAPA, product, and process improvement initiatives from initiation through sustained implementation, delivering measurable business impact.
* Demonstrates strong expertise in validation, including protocol development, execution, and lifecycle management for equipment, processes, and systems in compliance with regulatory requirements.
* Support daily manufacturing activities and resolve line issues.
* Develop and maintain quality systems, procedures, and documentation.
* Provide technical support for incoming inspection and lot release testing.
* Manage customer complaints and non-conformance investigations.
* Lead internal and external audits (FDA, ISO, MDD).
* Oversee supplier quality activities including audits and corrective actions.
* Support engineering teams in product development and process improvements.
* Conduct statistical analysis, validation testing, and Gage R&R studies.
* Mentor junior quality staff and provide training as needed.
Qualifications
* Bachelor's degree in engineering, science, or related technical field.
* Minimum 8 years of quality engineering experience in regulated industries (medical device or pharmaceutical preferred).
* Experience with ISO 13485, ISO 14971, FDA QSR, IEC 60601, and related standards.
* Proficiency in statistical tools and software (Minitab preferred).
* ASQ certifications (CQE, CQA) and Six Sigma Green/Black Belt preferred.
* Demonstrates working knowledge of sterilization methods and controls and their impact on product quality, including validation, change control, and compliance requirements (preferred).
* Excellent communication, technical writing, and project management skills.
* Ability to travel up to 10%.
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Interested?
If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.
About Nordson Medical
At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.
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