Design Assurance Project Manager - Contractor
Join to apply for the Design Assurance Project Manager - Contractor role at Nordson MEDICAL.
Location: Galway, Ireland
Contract Duration: 6 months, 3 days per week.
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. As a Project Manager, you will be responsible for assuring product quality, safety and effectiveness.
Role And Responsibilities
* Lead Quality Representative on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record documentation.
* Ensuring project teams are utilizing Nordson Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
* Investigating and evaluating material biocompatibility and appropriate methods of sterilization during the product design cycle.
* Conducting risk assessments of the design to determine ability to function as intended.
* Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.
* Interacting with customer and supplier companies in a professional manner; proactively communicating with them to ensure an ongoing two-way exchange of information.
* Ensuring that all work satisfies the requirements of the company's Quality Manual.
* Continually looking for improvement and compliance improvement opportunities.
* Leading Quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes or products to bring concept to market.
* Maintaining detailed documentation throughout all phases of research and development.
* Conducting and/or participating in meetings directly with clients.
* Coordinating activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
Skills And Qualifications
* Minimum Bachelor's degree in Engineering or related field.
* 10 years of medical device design and development/quality assurance experience is required.
* Ability to interact with client companies in a professional manner.
* Demonstrated ability to lead product verification & validation activities.
* Familiarity with FDA QSRs, medical device regulations and ISO 13485.
* Organised and able to self-manage project tasks.
* Customer focus with excellent communication skills, written and oral.
* Depth of knowledge in one or more clinical areas.
* Experience using an electronic quality management system (eQMS) is a plus.
* Lean or Six Sigma certification/experience preferred.
* Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
About Nordson Medical
At Nordson Medical, we value diversity and inclusivity in all aspects of our business. We are an equal opportunity employer and welcome candidates of all backgrounds, experiences, and perspectives to apply.
Interested?
If you are interested in being a part of a team that is dedicated to improving the lives of patients through innovative medical technology and creating an inclusive and diverse workplace, please apply online with your CV.
Seniority level
Mid-Senior level
Employment type
Part-time
Job function
Project Management, Quality Assurance, and Product Management
Industries
Medical Equipment Manufacturing
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