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Design Quality Engineer (Maple Grove)
EntegeeMaple Grove, MN, USjob_description.job_card.1_day_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.part_time
job_description.job_card.job_descriptionApply clinical expertise to guide device testing and design decisions. Develop, direct, and execute design control and risk management plans for complex projects, independently or in collaboration with cross-functional teams. Lead the development and implementation of product risk management tools, including Hazard Analysis, Fault Tree Analysis, and FMEAs. Provide quality input as a subject matter expert (SME) and / or independent reviewer at key project milestones (e.g., design reviews, project design plans, design / process changes). Promote and ensure compliance with company quality systems, business processes, health & safety standards, and applicable market / regulatory requirements. Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Demonstrate proficiency in validation and statistical techniques to ensure compliance with regulatory requirements and internal standards. Maintain expertise in pharmaceutical and combination product regulations, including 21 CFR 211 and ICH Quality Guidelines. Stay current with ISO, EN, FDA, MDR, and other product developmentrelated regulatory requirements, and communicate updates to the Product Development team. Foster a culture of quality-driven, patient-centric product development and customer satisfaction.
Design Quality Engineer - Maple Grove, MN
Hybrid Schedule
Pay Rate : $45-50+ per hour
Qualifications :
- Bachelors degree with 58 years of experience, Masters degree with 36 years, or PhD with 03 years.
- Experience in design control and risk management of next-generation medical devices.
- Background in pharmaceutical or combination products, with knowledge of 21 CFR 211 and ICH Quality Guidelines.
Responsibilities :
Quality & Compliance Expertise :
Culture & Leadership :
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Design Quality Engineer • Maple Grove, MN, US
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