Engineer I, Design Quality

Job Description

Job Description

Job title: Engineer I, Design Quality

Location: San Clemente, CA

Pay Rate: $32-$37/hour on w2

Job Description:

Provide quality support for ICU Medical Consumable development and DHF Remediation. The Quality Engineer will support activities such as CAPA investigations, design projects, and will ensure compliance with ICU Medical 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)

Minimum Qualifications, Education & Experience

• 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.

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

Company Description

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.