More jobs:
Engineer , Design Quality
Job in
San Clemente, Orange County, California, 92673, USA
Listed on 2026-07-01
Listing for:
LanceSoft Inc
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
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)
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
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