This opportunity is with a globally recognized medical device company focused on enhancing the treatment of vascular conditions. Senior Quality Assurance Engineer will offer Process and Quality Engineering support to product development teams to ensure the creation of top-quality new products. Serve as the liaison between cross-functional departments, such as Research and Development, Operations, and other Quality functions. Must be capable of analyzing data and aiding in its interpretation. Develop and implement improvements to the investigation process.
Key Responsibilities:
- Ensures compliance with relevant corporate and divisional policies and procedures. Estimates project effort and resource needs using standard estimation techniques and tools, collaborating with appropriate staff to understand the project scope.
- Develops project plans, schedules, and budgets utilizing project management tools such as Microsoft Project, working closely with staff to identify the necessary tasks for project completion.
- Oversees project execution by assigning tasks, monitoring schedules, identifying risks, and creating and implementing contingency plans.
- Provides regular project updates through standard status reports and participation in departmental and customer project status meetings.
- Addresses project issues by collaborating with team members, project stakeholders, and other relevant parties.
- Translates business strategies into clear objectives and daily activities needed to achieve them.
- Identifies and manages manufacturing process defects (including scrap, nonconforming materials, and customer complaints) by participating in teams focused on root cause analysis and implementing corrective and preventive actions. May be responsible for data analysis to support complex implementations and documentation of release criteria.
- Develops product quality plans, documentation, and systems by creating product and quality specifications in collaboration with other product development team members. May also be responsible for conducting risk analyses and Failure Mode and Effects Analysis (FMEA).
Education & Experience:
- Level 7 qualification in a relevant discipline and 4+years of related work experience.
- Strong understanding of business unit function and cross group dependencies/relationships. Will perform this job in a quality system environment.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. May interact with vendors.
For a confidential discussion and more information on the role, please contact Alicja Burchardt.
alicja.burchardt@collinsmcnicholas.ie
0212427109