Our client, a leading medical device manufacturer, has instructed us to search for a Quality Assurance Specialist with experience in medical device manufacturing. 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. For more information call Cormac Spencer on 01 845 4651

The role reports to the QA Manager

Salary: to €60k

Benefits: Flexible Working, Bonus, Pension, Gym and Sports and Social, Healthcare, Generous Holidays

Duties:

• Contributing on various Quality Assurance activities onsite supporting the manufacture of large IVD instrumentation. Working collaboratively across the manufacturing site with engineering, production and procurement
• Supporting a focus on and commitment to Quality in the manufacture of our 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.

Competencies

• 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.
• Experienced 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.

Background / Qualifications:

• 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.
• 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) and Interface to Product Lifecycle tools such as SAP, Teamcenter or other.
• Ability to present and communicate internally and with to external auditors.
• Understanding of Biochemistry, Immunology, Hematology Diagnostic Technologies would be an advantage.

If this Quality Assurance Specialist role sounds like YOU, Call US on 01 845 4651

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