Senior Quality Assurance Engineer Role
This opportunity is with a globally recognized medical device company focused on enhancing the treatment of vascular conditions.
Job Description:
As Senior Quality Assurance Engineer, you will offer Process and Quality Engineering support to product development teams to ensure the creation of top-quality new products. You will serve as liaison between cross-functional departments, such as Research and Development, Operations, and other Quality functions. Your ability to analyze data and interpret it effectively is crucial in aiding process improvements.
Key Responsibilities:
1. Ensure compliance with relevant corporate and divisional policies and procedures.
2. Estimate project effort and resource needs using standard estimation techniques and tools, collaborating with appropriate staff to understand project scope.
3. Develop project plans, schedules, and budgets utilizing project management tools like Microsoft Project, working closely with staff to identify necessary tasks for project completion.
4. Oversee project execution by assigning tasks, monitoring schedules, identifying risks, and creating contingency plans.
5. Provide regular project updates through standard status reports and participation in departmental and customer project status meetings.
6. Address project issues by collaborating with team members, project stakeholders, and other relevant parties.
7. Translate business strategies into clear objectives and daily activities needed to achieve them.
8. Identify and manage 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.
9. 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).
Requirements and Qualifications:
* Hold a Level 7 qualification in a relevant discipline and have 4+ years of related work experience.
* Have a strong understanding of business unit function and cross-group dependencies/relationships. This role will perform in a quality system environment.
* Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
* May lead a project team. Participate in determining goals and objectives for projects. Influence middle management on technical or business solutions. May interact with vendors.