Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated Manufacturing Quality Engineer to join our team. We are committed to creating a diverse and inclusive workplace and are looking for candidates who share that 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 the Position
The Manufacturing/Regulatory Quality Engineer ensures that manufacturing processes, products, and systems comply with validations, customer specifications, quality and manufacturing specifications, control plans, and relevant international standards. The role collaborates cross‑functionally within the business unit, assists the Quality Department with investigations of non‑conforming events and complaints through root cause analysis and CAPA implementation, updates and maintains product regulatory requirements, and trains technicians, TPAOs, and PAOs to ensure compliance with the Quality System.
Principal Duties and Responsibilities
Act as the Manufacturing Lead for investigating non‑conforming materials and complaints, using data analysis and problem‑solving techniques to identify root causes and corrective & preventive actions.
Provide regulatory support for new products and support to Operations, Sterilisation and Labelling/Packaging.
Review and update regulatory documentation to ensure compliance with ISO standards, FDA guidelines and EU directives.
Conduct process audits of manufacturing lines to ensure product compliance and that equipment/process adhere to SOPs.
Identify and suggest improvements to current equipment, processes, and procedures to streamline manufacturing activities while maintaining high quality standards.
Collaborate with the Manufacturing Engineer to advise on processes that require investigation or development, aiming to improve robustness.
Participate actively in continuous improvement projects, delivering on commitments and proposing alternatives.
Support the Manufacturing Engineer and cross‑functional teams in data collation and resolution of processing issues.
Promote quality within the manufacturing group and assist the Quality Department in introducing initiatives.
Lead manufacturing‑driven initiatives related to quality within the department.
Review batch records and lot history to ensure GMP/GDP compliance before final QA release.
Maintain effective communication within the team and foster cross‑functional relationships.
Conduct training and competence assessments with manufacturing personnel on changes introduced.
Ensure all products meet specifications, performance and quality criteria of end users, customers, regulatory authorities and the company.
Maintain work areas, equipment, and supplies in compliance with Vention quality system, 5S, GMP and safety requirements.
Person Specification
Engineering/Science discipline qualifications.
Medical device manufacturing experience of 4+ years.
Hands‑on experience in medical device manufacturing.
Good working knowledge of production and quality system requirements (13485:2003, FDA QSR Part 820).
A Green or Black Belt in Lean Six Sigma is a distinct advantage.
Strong communication and influencing skills.
Ability to manage a simultaneous range of diverse activities.
Self‑starter with good motivation and interpersonal skills.
Practical, level‑headed individual with strong technical ability.
Hands‑on engagement with cross‑functional groups, equipment and vendor personnel to resolve technical issues.
Structured approach to problem‑solving using data.
Interested?
If you want to be part of a team that creates 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 designing, developing and manufacturing complex medical devices and component technologies. Our supportive culture and dynamic environment invite you to bring innovative ideas to life, whether you’re just beginning your career or are a seasoned professional. We offer hourly and salary positions across production, maintenance, customer service, quality, engineering, and more, and actively invest in our teams to develop and advance careers.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Engineering and Information Technology
Industries
Machinery Manufacturing
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