JOM AKEM-015176

Quality Assurance Scientist

Location: Co. Galway


Reporting to Director Innovation Insights. You will be part of the world leader R&D organisation. You will be responsible of the implementation and compliance to relevant quality system regulations and standards for the R&D organization. In particular, you will play a key role in developing, deploying, and maintaining R&D documentation in compliance with ISO13485.

Responsibilities

• Project team member for ISO13485:Write/update QMS Elements, procedures, processes, forms, and templates for R&D organization.
• Manage R&D actions arising from Project Work Breakdown structures, and ensure common templates and formats are being followed by R&D teams.
• Work with QMS specialist to ensure the Design and Development process scope is clearly defined, understood, and supported by a compliant SOP.
• Ongoing Maintenance of Documentation, systems, and processes, to ensure ongoing R&D compliance to the Standard in subsequent surveillance audits, the candidate is expected to partake in an internal auditor role.
• Support R&D organization in the technical writing of Test/Study Protocols, Test methods and SOP’s, or reports as needed.
• Support on training documentation –templates, procedures, with regards to ISO13458 and QMS.
• Full understanding of the product development requirements, with emphasis on the definition, verification, and validation of the Critical to Quality requirements.
• Product Inspection knowledge, working with the production sites and reference inspectors, develop an understanding of the inspection standards and setup that apply for existing and new products, programs, or technology changes.

• Bachelor's degree in chemistry, or similar technical field, with a minimum 3 years relevant Quality experience in a regulated environment (ISO13485/FDA).
• Proven ability to collaborate with cross-functional teams.
• Attention to detail & systematic approach to work.
• Strong Interpersonal skills.
• Strong presentation and communication skills.
• Technical Writer experience
• Internal Audit Training (ISO13485)
• Industry experience in the ophthalmic/optical sector.
• Experience with Design Control for New Product Development.