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.
Purpose of position:
The Manufacturing/Regulatory Quality Engineer's role is to ensure that the Manufacturing Processes, Products, and Systems are in compliance with the requirements set out in Validations, Customer Specifications, Quality & Manufacturing Specifications, Control Plans, and relevant International Standards as applicable.
The role will involve collaborating cross-functionally with various departments within the business unit.
The role will also involve assisting the Quality Department with investigations into Non-Conforming Events and Complaints, by providing Root Cause Analysis and CAPA identification & implementation.
The role will also involve the update/maintenance of product regulatory requirements.
The role shall also involve training of Technicians, TPAOs, and PAOs to ensure manufacturing personnel are compliant with the requirements of the Quality System
2. Principal Duties and responsibilities:
Act as the Manufacturing Lead with respect to the thorough investigation of Non-Conforming Materials and Complaints, using Data Analysis/Problem Solving Techniques to arrive at Root Cause and identify Corrective & Preventative Actions to prevent recurrence
Provide regulatory support for new product and support to Operations, Sterilisation and Labelling/Packaging.
Review and update of Regulatory documentation to ensure compliance with current ISO standards, relevant FDA guidelines and EU Directives.
Process Audits of the manufacturing lines to ensure the product being manufactured complies with all requirements, and that the Equipment/Process in use complies with the relevant Standard Operating Procedures
Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality
In conjunction with the Manufacturing Engineer, provide advice and support to processes that require investigation or development with the goal to improve and make robust.
Be an active Team Member on Continuous Improvement Projects by delivering on actions committed to, critiquing current methods, and suggesting alternatives/improvements.
Support the Manufacturing Engineer and cross functional teams on the collation of data and the resolution of processing issues.
Actively promote Quality within the Manufacturing group, and assist the Quality Department on introducing initiatives into the Manufacturing Department
Lead Manufacturing Driven initiatives with respect to quality within the department
Batch Record/Lot History Review to ensure Product Compliance/GMP/GDP are as per relevant procedures prior to final QA Release.
Maintain effective open communication within the team and foster cross- functional relationships
Conduct Training and Competence Assessment with manufacturing personnel on changes being introduced as required
Ensure that all products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities and the company.
Maintain work areas, equipment and supplies in a manner which conforms to the requirements of the Vention quality system, 5S, GMP and safety.
3. Person Specification:
The Manufacturing Quality Engineer will have Engineering/Science discipline qualifications.
Medical device manufacturing experience is essential, 4 plus years.
Hands on experience in Medical device manufacturing are essential.
Must have a good working knowledge of production and quality system requirements in the health care industry (13485:2003 and FDA QSR Parts 820)
A Green or Black Belt in Lean Six Sigma would be a distinct advantage.
S/he needs strong communication and influencing skills.
Have the ability to effectively manage a simultaneous range of diverse activities.
Be a self-starter with good motivational and inter-personal skills.
A Practical level-headed individual with strong technical ability.
Have an ability to work hands-on engaging with cross-functional groups, equipment and materials vendors to resolve technical issues.
A structured approach to problem solving based on the utilisation of data.
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.