Design Quality Engineer I

Position Summary
Provide quality support for Consumable development and DHF Remediation. The Quality Engineer will support activities such as CAPA investigations, design projects, and will ensure compliance with *** quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards.

Essential Duties & Responsibilities
" Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
" Assures conformance with regulations of the FDA and other international regulatory agencies.
" Ensure all Quality attributes for design changes are met.
" Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
" Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
" Support any potential internal and/or external audits and inspections.
" Effectively interact with cross-functional team members.
" Provide quality support and for on-market product issues. Bring issues to closure and escalating to management for support as necessary.
" Work special projects as assigned

Knowledge & Skills
" Experience in quality engineering, product design or product engineering.
" DHF Remediation
" EU Medical Device Regulation 2017/745 (EU MDR)

Applicants must be legally authorized to work in the United States for the anticipated duration of the assignment. Neither the client nor the supplier will provide sponsorship for an employment-based visa in connection with this assignment.

Quals--
Minimum Qualifications, Education & Experience
" Must be at least 18 years of age
" Bachelor s degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
" Minimum of 0 - 2 years of experience in R&D and/or Quality is required.

Work Environment
" This is largely a sedentary role.
" This job operates in a professional office environment and routinely uses standard office equipment.
" Typically requires travel less than 5% of the time

Applicants must be legally authorized to work in the United States for the anticipated duration of the assignment. Neither the client nor the supplier will provide sponsorship for an employment-based visa in connection with this assignment.