Lead Quality Engineer

Job Description Summary

As directed by the Quality Manager, the Lead Quality Engineer 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.
Works under general direction while independently determining and developing approaches to
solutions. Frequent inter-organization contacts to achieve stated objectives.

Job Description

Primary Responsibilities
• Support design control projects.
• Writes and leads risk management activities.
• Support the efforts in creation of specifications, design, and test methods for the new products.

• Translate customer needs into engineering requirements into specific product, packaging
and process specifications.
• Write detailed technical reports based on design verification analysis/testing for design
changes and product design activities
• Interface with manufacturing on an ongoing basis during the development stages to ensure
manufacturability of the design solutions.
• Consistent application of technical principles, theories, concepts, and quality sciences /
tools.
• Proven problem-solving skills
• Ensures that all design control and production / process control projects meet applicable
regulatory (local and international), Corporate, and Unit requirements.
• Is a team member representing Quality on new product development and sustaining
engineering projects.
• Reviews and has Quality Engineering approval authority for new and modified design /
process specifications including product performance specifications, test methods, etc.
• Assists with supplier and internal quality system audits as a means of evaluating the