Sr. Design Quality Engineer

Role Name:                      Sr. Design Quality Engineer

Location:                          Plano, TX (Onsite)

Duration                           10-12+ months with possible extension

Job Description:

As the Sr. Design Quality Engineer you will assure new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Required Qualifications:

•        Bachelor’s Degree in Engineering, Technical field OR an equivalent combination of education and work experience.

•        5+ years of previous quality engineering experience and demonstrated use of quality tools/methodologies.

•        Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.

•        Strong analytical/problem solving, critical thinking, and presentation skills.

•        Demonstrates initiative, ownership and accountability ; plans, prioritizes and meets deadlines.

•        Advanced computer skills, including statistical/data analysis and report writing skills.

Preferred Qualifications:

•        Master’s Degree in Engineering or Technical Field.

•        Previous Medical Device design and development experience.

•       Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-1, ISO 14708, EU MDR, etc.