Quality Design Engineer

CONTRACTUAL ROLE

Location:PUNE

Experience:5+ YEARS

• Bachelors degree in Engineering, Quality, or a related field (Master’s preferred).
• 5+ years of experience in medical device quality engineering or a related field.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
• Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
• Proficiency in statistical analysis tools (Minitab, JMP, Excel) and problem-solving methodologies (8D, DMAIC).
• Certified Quality Engineer (CQE) or Six Sigma certification is a plus.
• Building Strategic Working Relationships-Developing and using collaborative relationships to facilitate the accomplishment of work goals.
• Quality Orientation-Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.
• Decision Making- Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
• Performance/Work Standards-Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks. (Flawless Execution of the Basics).

Information Monitoring- Setting up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it.

If you are comfortable with contractual position,Ready to relocate and Immidiate Joiner then mail me at [email protected]