Engineer I, Design Quality

Position SummaryProvide quality support forConsumable development and DHF Remediation. The Quality Engineer will support activities such as CAPA investigations, design projects, and will ensure compliance withquality 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 & ResponsibilitiesEffectively 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 & SkillsExperience in quality engineering, product design or product engineering.DHF RemediationEU Medical Device Regulation 2017/745 (EU MDR)

Quals--Minimum Qualifications, Education & ExperienceMust be at least 18 years of ageBachelor 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 EnvironmentThis 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