Senior Quality Engineer

Project:

The projects currently in progress are a material change of an existing component, and a revision of IFUs across a wide spectrum of products. However, the project load in general is dynamic and changes over time, being primarily sustaining related design control product changes (i.e., vendor-driven changes mostly).

Job Summary:

This position is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Job Responsibilities:

Consistent application of technical principles, theories, concepts, techniques and quality sciences/tools (e.g. Acceptance sampling theory and application, statistical process control methods and application, measurement systems/test method knowledge and analysis, quality planning, failure analysis and investigation, design of experiments, process mapping and value stream analysis, hypothesis testing, descriptive statistics, process capability analysis, basic quality tools: pareto, box plots, histograms, scatter diagrams etc., risk management, supplier quality management, auditing, design/development tools, process validation, software validation, etc.).

Education and Experience:

• Requires a minimum of a bachelor’s degree.
• A minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.
• Candidates must have experience within the medical device or equivalent regulated industry.
• Working knowledge of statistical analysis and software use (Minitab preferred).
• General application of design controls.

Preferred skills:

• Process validation experience (IQ/OQ/PQ).
• Design change experience, including: Design verification / Design validation / Risk management
• Corrective and Preventive action.