Quality System Developer

24 hours ago

Limerick, Limerick, Ireland beBeeDesign Full time €80,000 - €100,000
Job Description

We are seeking a qualified professional to develop and refine quality system policies and procedures for new product development (NPD). The successful candidate will work closely with stakeholders and regulators to ensure that our policies and procedures meet their needs and expectations.

Key responsibilities include:
  • • Interpreting standards, regulations, and guidance documents to tailor these needs into systems which meet requirements and offer a usable approach

    • Developing effective solutions capable of meeting global needs

    • Developing systems which can be operated effectively by personnel and build usability into the processes to drive robust product designs and manufacturing processes

    Reporting to: Manager, Quality Assurance

Responsibilities

We are looking for a collaborative team player who can work across Global Research and Development, Cook Medical Quality Systems, and functional stakeholders in the divisions, functional units, and operational units to develop and implement global policies and procedures. The ideal candidate will have experience developing and managing policies and procedures, as well as working in a global environment and managing complex projects/programs in an engineering environment.

The selected candidate will participate in internal/external audits and act on assigned audit responses/CAPAs. Additionally, they will monitor Design Controls, Process Development, and Risk Management CAPAs and internal/external audit feedback from the manufacturing operations entities' quality systems and evaluate impacts to Cook Medical's global policies and procedures.

We are committed to ensuring that all quality, regulatory, compliance, and product-specific requirements are met. Our Code of Conduct is considered in all business matters carried out on our behalf.

Qualifications

A Bachelors Degree required in Engineering or Science, preferably in Mechanical, Chemical, Manufacturing or Biomedical disciplines. A minimum of 5 years' 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

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