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Quality Assurance Engineer

Company: Actalent
Location: Durham
Posted on: November 26, 2022

Job Description:

Description:This is a biotechnology company comprised of light and life scientists with focus on the highly specific use of light to stimulate physiological signals and initiate healing at the cellular level. The Company targets using this proprietary technology platform to enable prophylactic and therapeutic treatments for high volume deployment to redefine the standard of care for a number of diseases and conditions.We are searching for a hands-on motivated candidate with experience in medical device design and development to work within our engineering team developing novel light-based technology platforms. This position will play a critical role in the engineering team by taking ownership of the key responsibilities outlined below. The right candidate will also be able to and readily utilize their personal strengths to contribute in other functional areas outside of the engineering team, including manufacturing, regulatory, and clinical.--- Design and develop deployable light-based medical devices from brainstorming to production--- Develop and maintain detailed, up-to-date, project schedules that ensure all activities and deliverables are completed within established milestones --- Communicate progress, identify potential risks or barriers, and present solutions to keep projects on-track--- Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.--- Generate design control documentation to support Design History Files and regulatory submissions.--- Author design verification, design validation, equipment qualification (IQ/OQ/PQ), and process validation protocols and reports --- Use appropriate quality tools and statistical techniques to determine sample sizes, design and analyze experiments, collect and summarize data, apply data distributions, draw conclusions with confidence, identify relationships between variables, calculate reliability, determine process and performance capability, and make statistically supported decisions. --- Investigate data anomalies and unexpected results to determine and understand the root cause--- Collaborate with suppliers to ensure appropriate documentation (manufacturing procedures, inspection records, FAI, etc) to support GMP and the Quality System compliance.--- Identify, investigate, disposition, and resolve nonconforming material events during product development, pre-production and production phases.--- Adhere to and ensure compliance with the Quality System.Skills:medical device, design controls, FDA submission, design history file, fda, quality assurance, de novo, 21 CFR 820, gmp, risk management, ISO 13485Top Skills Details:medical device,design controls,FDA submission,design history fileAdditional Skills & Qualifications:Required Skills & Qualifications:--- BS or MS in an engineering or science field --- 5-12 years of industry experience testing small to medium size electro/opto-mechanical systems. --- Detailed knowledge if ISO 14971/24971 and demonstrated expertise of risk analysis methodologies--- Demonstrated ability to collect, analyze, and succinctly present the key findings with MS Excel, JMP, R, or other similar data analysis tools.Desired Skills and Qualifications:--- Prior experience with Computer System Validation--- Prior experience with Human Factors and Usability Engineering--- Prior experience with IEC 60601-1 and associated collateral or particular standards --- Working knowledge of Quality System Regulation (21 CFR 820) or ISO 13485--- Experience with optical components, basic hand tools, measurement tools, prototyping, and assembly methods.Experience Level:Intermediate Level About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Durham , Quality Assurance Engineer, Engineering , Durham, North Carolina

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