Engineer III, Design Quality - Hardware & Consumables
Engineer III, Design Quality - Hardware & Consumables
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$ 113069 - 154560
1 Vacancy
Job Description
Engineer III Design Quality - Hardware & Consumables San Clemente CA
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. Provides compliance guidance concerning development application and maintenance of quality standards as related to product development within the quality system. 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. Maintain design history files (DHF) up to date as needed. 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. *Hybrid work is permissible. When not working from home must report to San Clemente CA office. *< 5% domestic travel required per year.
EDUCATION AND EXPERIENCE REQUIREMENTS:
Bachelors degree (or foreign equivalent) in Industrial Engineering Mechanical Engineering Biomedical Engineering Information Technology or closely related field plus Four (4) years of experience in the job offered or a closely related occupation.
SPECIAL REQUIREMENTS:
Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be quantified by time. Required expertise/knowledge includes: Knowledge of the Medical Device Industry and hands on experience in ISO 13485 FDA 21 CFR 820 QSR Regulations and MDR regulation for medical devices in the European Union (EU); Experience managing Design Control elements Design History Files and Device Master Records; Experience supporting 510K and Technical File submissions for new product development or substantial design changes; Experience creating Design V&V protocols and reports; Experience initiating and managing Risk Management documents per ISO 14971 (Hazard Analysis DFMEA PFMEA etc.); Experience with Root Cause Analysis tools (e.g. Cause and effect analysis) risk assessments and associated CAPA activities; Understanding of Continuous Improvement tools such as Six-Sigma PDCA; Knowledge in Statistical Techniques for analysis of data for both process and design (e.g. Cpk statistical tolerance limit etc.); Experience with quality compliance and internal / external audits.
ICU Medical Inc. is an equal opportunity employer.
40 hours per week / $113069 - $154560 per year
To apply for ICU Medicals Engineer III Design Quality - Hardware & Consumables position please send resume to:
Must reference JOB CODE: CA0521VK
Employment Type
Full-Time
