Quality Engineer - Temp
About The Position
At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities. POSITION SUMMARY The Quality Engineer will be a part of the Quality Assurance team at Genalyte. This role will be responsible for ensuring compliance with applicable regulatory requirements and standards, maintaining quality system processes, and supporting the development and manufacture of IVD products. This is a temporary position.
Requirements
- A minimum of a Bachelor’s degree in Engineering, Life Sciences, or a related field with 3 years of experience in quality engineering within the medical device or IVD industry
- Strong knowledge of ISO 13485 and FDA QSR
- Proficiency in quality tools and methodologies, such as FMEA, SPC, and Root Cause Analysis
- Experience with CAPA, nonconformance investigations, and risk management
- Excellent problem-solving, analytical, and organizational skills
- Strong communication and collaboration abilities
Nice To Haves
- Certified Quality Engineer (CQE) or equivalent certification
- Experience with statistical analysis tools and software
- Familiarity with software quality assurance for medical devices
Responsibilities
- Maintain and improve Quality Management System (QMS) processes in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulatory standards
- Conduct internal audits and support external audits, including regulatory inspections
- Support product design team in the development and release of product specifications and documentation
- Collaborate with cross-functional teams to ensure design controls, risk management, and product validations comply with regulatory and quality requirements
- Participate with design teams in the development of quality requirements, acceptance criteria and test methods for components, assemblies and devices
- Participate in design reviews and ensure proper documentation of design history files (DHF)
- Support phase gate reviews for development projects at scheduled intervals and ensure compliance to design control regulations
- Prepare quality related deliverables per the design control process
- Work closely with product teams to develop and approve manufacturing process documents (procedures, work instructions)
- Develop manufacturing process quality requirements and methods needed to support manufacturing
- Prepare or support equipment qualification and process validation protocols release, execution and reports
- Working with Supply Chain and QA, qualify suppliers in accordance with company processes and regulatory requirements
- Evaluate and monitor supplier performance to ensure materials and components meet specifications
- Perform acceptance activities for supplied materials, as needed
- Ensure proper documentation and traceability of quality records, including complaints, deviations, and change controls
- Perform quality trend analyses to demonstrate quality system effectiveness and compliance
- Other tasks as assigned
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What This Job Offers
Career Level
Mid Level
