Our client a major multinational based here in Galway are looking to hire a Senior Quality Engineer for aninitial 12 contract to support an exciting new project.
Working Model: Hybrid or Remote options.
The Role:
As the Senior Quality Engineer you will work within Quality team and you will be responsible for implementing, maintaining the quality management system, ensuring effective compliance in accordance with regulatory requirements.
Responsibilities:
Carries out duties in compliance with established business policies and procedures.
Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
Remains current with regulations and standards.
Support the continuous improvement of quality system processes.
Assist in the preparation and maintenance of records associated with the management review process including metrics.
Apply problem-solving skills in order to deal creatively with moderately complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve.
Drive compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration.
Owning and completing CAPAs in Agile PLM.
Authoring and maintaining procedures, work instructions, forms, and templates to ensure that processes are compliant with Corporate policies, external quality standards/regulatory requirements and customer (Entity) requirements.
Support other QMS activities as required.
Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.
Execute and provide on-time completion of Quality Assurance deliverables.
Provide support and subject matter expertise during audits and inspections.
Lead and/or contribute to continuous improvement initiatives and projects.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Requirements:
Bachelor’s Degree / master’s degree in a science or technical discipline
5+ years’ experience in a Quality Assurance/Systems engineer role within a relevant regulated industry plus demonstrated competence.
Detailed knowledge of FDA QSR (21 CFR Part 820), GMP, MDSAP, IVDR and ISO 13485.
Solid communication and interpersonal skills.
Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
Preferred:
Prior medical device experience.
Six Sigma root cause analysis/problem solving training and experience.
Significant CAPA management experience and previous experience in mentoring CAPA owners.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717