Quality Assurance Expert
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This is an exciting opportunity to work with a leading medical device company, contributing to the development of innovative solutions for vascular conditions.
We are seeking a highly skilled Quality Assurance Engineer to provide expertise in process and quality engineering, ensuring the creation of high-quality products.
The ideal candidate will serve as a liaison between cross-functional departments, such as Research and Development, Operations, and other Quality functions.
Must be able to analyze data and aid in its interpretation. Develop and implement improvements to the investigation process.
Key Responsibilities:
* Ensure compliance with relevant corporate policies and procedures.
* Estimate project effort and resource needs using standard estimation techniques and tools, collaborating with appropriate staff to understand the project scope.
* Develop project plans, schedules, and budgets utilizing project management tools, working closely with staff to identify necessary tasks for project completion.
* Oversee project execution by assigning tasks, monitoring schedules, identifying risks, and creating contingency plans.
* Provide regular project updates through standard status reports and participation in departmental and customer project status meetings.
* Address project issues by collaborating with team members, project stakeholders, and other relevant parties.
* Translate business strategies into clear objectives and daily activities needed to achieve them.
* Identify and manage manufacturing process defects 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.
* Develop 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.