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Engineer I, Design Quality
Job Description
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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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
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