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Sr. Quality Engineer

4 months ago

Minneapolis, United States Cypress Human Capital Management, LLC Full time

Sr. Quality Engineer – Med Device

The senior quality engineer is tasked with implementing, sustaining, and enforcing the internal quality management system to meet ISO standards and FDA quality system regulations. This pivotal role involves close collaboration with development and manufacturing teams to establish and assure compliance with the quality system throughout the development cycle. Additionally, this position spearheads the development and execution of inspection/validation processes crucial for verifying product compliance.

Responsibilities

Ensure the company's compliance with Quality System and GMP/ISO standards, continuously enhancing quality system procedures. Collaborate with Engineering, Marketing, Manufacturing, & Regulatory teams to define measurable, valid product requirements. Develop and document protocols, procedures, and reports for product, process, and equipment testing. Execute tests according to requirements. Lead activities related to risk management and analysis. Create design verification and validation plans for products based on performance specifications and risk analysis. Oversee transition and communicate adherence to specifications, regulations, and applicable international standards. Assist in defining and completing in vitro and in vivo testing, including relevant animal studies. Lead in defining and measuring process capability, process controls, and process validation. Establish supplier quality specifications, sampling plans, and vendor qualification in accordance with the quality system. Assist in specifying and testing sterilization methods.

Requirements

Bachelor of Science in an engineering discipline or technical field required; advanced degree preferred. Experience in the medical device industry. Familiarity with FDA, GMP, and ISO 13485 standards; previous experience with QSR implementation preferred. Proficiency in advanced computer skills, including statistical/data analysis and protocol/report writing. Demonstrated ability to effectively communicate concepts, ideas, and knowledge to individuals and teams. Strong analytical and problem-solving skills, with a solid background in medical device development processes. Comfortable collaborating and seeking optimal solutions with team members across various engineering disciplines.

Pay Range

$100-120k

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