Senior Quality Engineer, Limerick

Work Flexibility: Onsite

 This is a 12 month onsite role in Limerick with full Stryker benefits.

Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issuesimpactingdaily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards.

Previousindustry experience desired. 

Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired. 

Understanding of US and International Medical Device Regulations.

Familiarity with ISO 13485, GDP, GMP desired.

Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

Mustpossessstrong communication, project management and influencing skills as well ashave the ability tomanage multiple tasks simultaneously.

Ability torepresentQuality function with project teams.

Strong interpersonal skills, written, oralcommunicationand negotiations skills. 

Strong in critical thinking and ""outside the box"" thinking. 

Highly developedproblem-solvingskills. Strong analytical skills.

Demonstrated ability to work independently and as part of cross-functional teams. 

Experience in working in a compliance risk situation. 

Computer literacy. 

Some travel may berequired.

Work closely with operations and the business functions to ensure quality performance of product and processes.

Collaborates with Divisional QA, cross-functional and suppliers’ teams to address top quality issues. 

Own identified internal and supplier driven non-conformances and manage thetimelyclosure of NC's within Trackwise. Own or supportidentifiedinternal CAPAs and manage totimelyroot cause investigation,implementationand closure. 

Disposition non-conforming product within MRB, issuingNC'sasappropriate. 

Communicate & collaborate with suppliersregardingnon-conformances, escalating supplier corrective action requests asrequired.

Engage in the development and improvement of the internal manufacturing processes for existing products.

Performs critical assessment of internal and supplier proposed change management activities.

Performs PPAP activities for supplier changes

Participates and may lead in the creation and/or review of new or modified procedures.

Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends,identifyingand activating onappropriateactionsas necessary.

Support execution and analysis of manufacturing related complaints and product field actions.

Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.

Collaborate withappropriate stakeholderstoidentifyand execute opportunities for supplier part certification.

Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.

Support the creation and maintenance of inspection methods and sampling. 

Applies statistical methods of analysis and process control to current operations.

Engage andinterface ininternal and external audits providing subject matterexpertise

Support the development and review of process and equipment validation/qualification and MSA of internal processes.

Execute internal quality deliverables associated with engineering changes, manufacturingtransfersand supplier-initiated changes.

Support manufacturing transfers to/from other plants/facilities, executingappropriate qualityactivities.

What you will need:Level 8 Degree in Science or Engineering2 years experience in QualityTravel Percentage: None