Staff Engineer, Quality Assurance - Cork, Carrigtwohill IDA Business & Technology Park Tullagreen

Work Flexibility: Hybrid or Onsite

This is initially a 23 month Fixed Term Contract

Who we want

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

What you will do

Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

• Work closely with operations and the business functions to ensure quality performance of product and processes.
• Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
• Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
• Analysis and review of concession requests.
• Review and approval of change management activities.
• Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
• Support execution and analysis of QATs.
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
• Proficient in risk management practices and tools, having high expertise in process risk.
• Develop and provide input for risk management by identifying opportunities and weaknesses.
• Proficiency in and makes continuous strides towards optimization of inspection methods and sampling.
• Support First Article Inspections.
• Proficiency in statistical methods and application.
• Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
• Assist in the development, responsible for review & approval of process and equipment validation/qualification.
• Support manufacturing transfers to other plants/facilities, leading quality activities.
• Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
• Coach and mentor others in quality topics and activities.

                                                                                                                                       

What you need

• This job would suit someone working in a quality engineering role or similar looking to progress their career
• Bachelor degree in Science, Engineering or equivalent/ related subject (Level 8)
• Ideally a minimum of 2 or more years experience
• Previous experience in a regulated environment desirable.
• CQE or equivalent course work / experience desirable.
• Proficient in understanding of Med Device manufacturing processes desirable.
• Familiarity with ISO 13485, GDP, GMP desirable.
• Lean Six Sigma training a distinct advantage.
• Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.

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