Job Description

Quality Assurance Professional - North Dublin

Ref No: AM17287

Co. Dublin, Ireland

Competitive salary

Quality Assurance Professional - North Dublin.

Our client seeks an experienced Quality Assurance Professional experience in medical device manufacturing in the areas of product and process quality assurance. This is an excellent opportunity to work with a leading global healthcare provider. The Quality Assurance team works cross-functionally with engineering, production and procurement with a wide range of responsibilities including Verifications, Validations, Non-Conformances, Temporary Deviations, Design Change, Process Change, Inspections/ Regulatory Audits, Complaint Handling, Risk, Calibrations, Design Transfers and Product Release.

The successful applicant will report directly to the Quality Assurance Manager on site and is a member of the site QA team, collectively responsible for maintaining and improving Quality & Compliance.

Core Responsibilities:
• Contributing to various Quality Assurance activities on site. Working collaboratively across the manufacturing site with engineering, production and procurement
• Supporting a focus on and commitment to Quality in the manufacture of products and services. Driving process measurement initiatives, including scorecards and other metrics, which are used to drive process quality improvements.
• Direct inputs and in some areas leading Quality Management system activities in areas including Validations, Process Change, Risk Assessment, CAPA, Complaint Handling, Non-conformances.
• Focus on and be responsible for process improvements and updating quality system procedures in Quality Assurance areas to achieve both fully compliant and lean processes.
• Using lean tools, own and lead quality projects that deliver quality, process and cost improvements
• Using of statistical analysis to support technical report writing to meet technical and regulatory standards of excellence. Examples include Gauge R&R, Capability Analysis, Sample Size Justification to support design changes, verifications, validations and deviations.

Interested applicants should have:

• Direct working experience in manufacturing quality assurance for production and process controls. Experience in Validations and Change management, in particular, would be an advantage.
• Demonstrated strong competencies and leadership to support fast-paced change in all or some of the listed areas of responsibility
• Ability to lead Quality process improvements, updating procedures and overseeing their timely implementation to achieve fully compliant and leaner processes. This will include leading and supporting initiatives to digitize and streamline processes.
• Ideally experience in the use of digital data analysis and measurement techniques to identify opportunities for process improvement.
• Identifying opportunities within existing quality & control systems to ensure processes for new products have improvements in place.
• Assessing manufacturing's capability to meet quality requirements based on digital data analysis and internal audit. Ability to create concise reports that enable project teams to implement improvements and corrective actions.
• Contributor to Risk activities associated with Product and Process.
• Design transfer support through the review and approval of plans and reports, ensuring they meet regulatory and technical standards. To ensure that new equipment and processes are fit for purpose and commissioned correctly.

You should have:
• Minimum of a Bachelor’s degree in a relevant technical discipline (ideally Science or Engineering)
A minimum of 8 years' relevant experience in a Quality role in the medical devices industry, within a highly regulated environment, with a core appreciation of global regulations including FDA.
• Strong leadership skills and ability to influence cross-functional teams to drive workscope to completion.
• Aptitude for systems level thinking, including development of standard operating procedures
• Ability to write structured, concise, unambiguous technical English with high attention to detail
• Core understanding of statistical analysis and design of experiment experience. Familiar with statistical software packages
• Computer literacy (including MS Word/ Excel/ Powerpoint/ MS Project). 
• Presentation skills whereby complex messages can be presented to an auditor/ inspector in a succinct manner.


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