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Details

Design Control Engineer


Reference:KG-AQMS-765381 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

In this role with a leading medical device company, you will develop and refine Global Design Controls, Process Development, and Risk Management quality system policies and procedures for new product development (NPD). Ensure quality system policies and procedures meet the needs of stakeholders and the expectations of regulators, in particular:

• Ensure the policies and procedures are compliant with applicable standards, regulations, and guidance documents.
• Interpret standards, regulations, and guidance documents to tailor these needs into systems which meet requirements and offer a usable approach for the company.
• Develop effective solutions capable of meeting global needs.
• Develop systems which can be operated effectively by personnel and build usability into the processes to drive robust product designs and manufacturing processes.

Qualifications
·Maintain our culture, values and commitment to ethics and compliance by recognising, demonstrating, and enforcing appropriate and compliant behaviour.
·Understand and be accountable for conducting business with integrity and in compliance with applicable standards, including internal policies.
·Within scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met.
·Ensure that the Code of Conduct is considered in all business matters carried out.
· Bachelors Degree required in Engineering or Science, preferably in Mechanical, Chemical, Manufacturing or Biomedical disciplines.
·Experience developing and managing policies and procedures.

·Experience working in at least one of the following areas
·R&D and/or new product development
·Process Development / Manufacturing Engineering
·R&D systems engineering – Design Controls, Process Development, and/or Risk Management
·Quality Assurance / Quality Engineering
·Effective oral and written communication skills.
·Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
·Experience working in a global environment / global teams across many cultures and regions, managing and executing complex projects / programs in an engineering environment.
·Willingness and availability to travel on company business.

If you would like further Information you can contact the recruiter directly:

Kevin Silke | Tel: +353 (0) 1 507 9255