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

Work Flexibility: Onsite

Senior Quality Engineer- 24 month contract

Who we are looking for:

The ideal candidate will provide quality engineering support 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. 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.

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 will need:
 

• Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline, or
• Masters of Science, Engineering or related subject with 0 years of 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.
• 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.
• Working 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)

Travel Percentage: None