Job ID R-303233
Job Description Summary
As directed by the Quality Manager, the Staff Quality Engineer I 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.
Knowledge - Extensive knowledge of applicable regulatory, Corporate and / or Business Unit requirements.
Skills - Training in design of experiments and statistics. Class II / III medical device experience. Knowledge of six sigma methodology preferred. Knowledge of design control principles (preferred). Ability to support internal / external audits.
Education/Degree - Bachelor’s Degree in scientific or engineering discipline
Certifications - Certified Quality Engineer and Certified Quality Auditor (preferred).
Experience - A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.