Ref No: AM17775
County Dublin, Republic of Ireland
Quality Professional - North Dublin.
This is a permanent role, and will suit candidates coming from either a science or engineering background.
You should have experience in product and process quality, including new product introduction. This is an excellent opportunity to work in a leading manufacturing facility. The quality function works cross-functionally with Engineering, Production and Procurement to cover a wide area of responsibilities such as CAPA, Non-Conformances, Risk Management, Deviations, Inspections and Regulatory audits, Complaint Handling, Validation and Product Release.
The Dublin site is currently involved in new product introductions, so this is an exciting time to join an existing team of Quality professionals to help develop the future processes of the manufacturing site.
The successful applicant shall report directly to the Product QA manager and is a member of the site QA team, collectively responsible for maintaining and improving quality & compliance in the manufacture and support of products and services.
Product & Process Quality:
• Work collaboratively with cross-functional stakeholders (Engineering, Production and Procurement) creating and ensuring value-streams comply with QMS requirements and production targets.
• Experienced in QMS covering a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing and process deviations, non-conformance handling and validation. You should be able to demonstrate strong competencies and leadership in these areas.
• Core contributor to risk activities related to verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, CAPA, continuous improvement changes, and post-production (proactive surveillance). This will require a systems mindset incorporating a cross technology understanding, in addition to a core appreciation of risk and regulatory requirements.
• Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control. Ability to develop into a mentor role for the quality, engineering and production teams is desirable.
• As a member of the site Quality team, you will focus on and be responsible for process design improvements and updating quality system procedures to achieve both fully compliant and lean processes.
• Using lean tools, own and lead quality projects that deliver quality, cost and process improvements.
• Assess manufacturing's capability to meet quality requirements based on data analysis and internal audit. As a follow-on activity create concise reports that enable project teams to implement improvements and corrective actions.
• Experienced in the use 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:
• Minimum of Bachelor’s degree in a relevant technical discipline (ideally Quality, Engineering or Science)
• At least 5 years' relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management, including writing and/or reviewing Quality related procedures, plans and reports.
• Strong leadership skills and ability to influence cross-functional teams to drive work scope to completion.
• Self-starter, bias for action with ability to follow assignment through to completion. Good organization skills.
• Cross-technology and cross-discipline collaboration skills.
• 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 e.g. Minitab.
• Computer literacy (including MS Word/Excel/PowerPoint/MS Project) and interface to Product Lifecycle tools such as SAP, Teamcenter or other.
• Presentation skills whereby complex messages can be presented to an auditor/ inspector in a succinct manner i.e. ability to present and to sell convincingly.