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.
- Follows all Quality Management System Requirements and participates in the development/modification of quality system protocols, quality system Requirements Manual, company Policies and directives.
- Quality Representative for Material Review Board (MRB) of components manufactured in the Easton facility
- Quality Representative for Change Control Board (CCB) of components manufactured in the Easton facility
- Owner of all inspection and test methodologies, and gage R&R including gage R&R between facilities.
- Participates in external audits
- Participates and approves specifications (input/outputs), verification and validation, risk management activities including DFMEA and PFMEA, Quality Plans and to assure products meet specifications.
- Manages larger scale projects or multiple smaller scope projects demonstrating strong project ownership, accountability, and strategic forethought.
- Provides Engineering studies as needed and statistical justifications
- Leads and execute engineering studies relating to Gage R&R, Cpk, SPC and Process Validations
- Leads and manage root-cause analysis as assigned relating to customer complaints, inquiries and product returns
- Implements ongoing quality improvement processes working with cross functional teams
- Conducts investigations and associated actions related to CAPA and Internal/external audit activities
Education and Experience Requirements
- Bachelor's degree in engineering or related discipline is required. A master's degree in engineering or related discipline is preferred and may substitute for some of the years of required experience.
- A minimum of five years related experience preferably in the medical device industry or a regulated environment such as aerospace.
- Strong working knowledge of ISO 13485:2003, QSR, ISO 14971 and related standards
- ASQ Certification (Auditing, Biomedical Auditing, Quality Engineering, Six Sigma Green/Black Belt) highly valued
- Experience with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required
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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.
