This is a 23 month fixed term contract based in Carrigtwohill.
Position Summary:
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 issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.
General Requirements:
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 required
Strong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics)
Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously
Ability to represent Quality function within and across the project teams
Strong interpersonal skills, written, oral communication and negotiation skills
Strong in critical thinking and outside the box thinking
Highly developed problem-solving skills,
Strong analytical skills
Demonstrated ability to successfully manage and complete projects in a matrix organisation
Demonstrated ability to work independently and as part of cross functional teams
Experience in working in a compliance risk situation
Previous industry experience required
Computer literacy
Some travel may be required
Key Areas of Responsibility :
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 non-conformances and manage the timely closure of NC’s
Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure
Disposition non-conforming product within MRB, issuing NCs as appropriate
Communicate and collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as required
Engage in the development and improvement of 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, identifying and activating on appropriate actions as 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 with appropriate stakeholders to identify and 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 and interface in internal and external audits providing subject matter expertise
Support the development and review of process and equipment validation/qualification and MSA of internal processes.
Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.
Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
Responsible for initiation, internal containment, and support of Commercial Holds for potential product escapes.
Drive continuous improvement actions to reduce manufacturing defects.
Provide leadership and subject matter expertise in QA activities to the overall site.
Qualifications:
BS in a science, engineering or related discipline
MS, CQE, or CRE preferred.
Six Sigma Green or Black belt preferred.
Minimum of 4 years’ experience preferred
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Travel Percentage: None