Quality Engineer III

Job Description :

The 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 process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Responsibilities : (Primary Duties, Roles, and / or Authorities) :

• Consistent application of technical principles, theories, concepts, techniques, and quality sciences / tools.
• Proven problem-solving skills.
• Makes measurable improvements to Client processes and procedures.
• Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
• cts as 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 specification, test methods, etc.
• ssists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training).
• May perform other duties as required.

Requirements :

Must have knowledge / specialization in one or more of the following areas :