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

Work Flexibility: Onsite

Job Title

Staff Engineer, Quality

Reports To

Associate Manager/ Manager/ Senior Manager, Quality Assurance

What we are looking for:

The chosen candidate will provide quality leadership and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.

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.
• Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.
• Initiates and lead in the development and improvement of the manufacturing processes for existing and new products.
• Oversight and leads investigations during concession management.
• Review and approval of change management activities, challenges change effectiveness and drives strong review.
• Interpret KPI trends, take action as necessary, driving a continuous improvement process.
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
• Subject matter expert 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 provides technical direction in optimization of inspection methods and sampling.
• High proficiency in statistical methods and application.
• Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Manages audit logistics and preparation.
• Aids in the development of validation strategies, certified in 1 or more areas of validation including approval of validation.
• 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 the quality team and others business function in quality topics and activities, with several topics at expert level.
• Deputises proficiently for management in temporary absence, periodic review boards, business meetings etc on a regular basis.

Qualification Knowledge Skills

• Bachelor degree in Science, Engineering or equivalent/ related subject and 4 years of work experience in a quality discipline, or
• Masters of Science, Engineering or related subject with 2 years of experience
• CQE or equivalent course work / experience desirable
• Proficient in understanding of Med Device manufacturing processes required.
• Proficient in ISO 13485, GDP, GMP.
• Lean Six Sigma training a distinct advantage.
• Excellent communication skills and attention to detail.
• Have a good understanding of engineering and quality practices & methods.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Must be willing to work as part of a multi-site team, with some travel required.
• High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
• Excellent English (both oral and written)
• Ability to be the voice of Quality when dealing cross functionally, will take the lead discussions / meetings to ensure the correct outcome.

Travel Percentage: None