Quality Control Technician Medical Device

Benefits 401(k) Competitive salary Dental insurance Flexible schedule Job Title: Quality Assurance Technician (V&V / NPI) Role Summary The Quality Assurance Technician plays a key role in maintaining product standards, focusing primarily on New Product Introduction (NPI) and Verification & Validation (V&V) activities. Collaborating closely with Quality Engineering, Manufacturing, and R&D teams, this position ensures all deliverables adhere to design specifications, industry regulations, and internal quality metrics across the entire product lifecycle. Primary Responsibilities V&V and NPI Operations Perform functional, performance, and durability test protocols according to approved methods. Configure testing hardware, custom fixtures, and sample units as specified in standard operating procedures. Document, process, and summarize test metrics following Good Documentation Practices (GDP). Log, report, and elevate test deviations or out-of-specification findings promptly. Participate in root cause evaluations and failure investigations. Work alongside R&D engineers to assemble prototypes, perform design iterations, and support early-stage build runs. Offer practical insights regarding quality concerns, testing feasibility, and design manufacturability. Compliance & Continuous Improvement Conduct all testing operations in alignment with ISO 13485, FDA guidelines, and internal quality policies. Draft, organize, and archive complete test logs, technical reports, and trace records. Support document management by drafting revisions for test procedures, work instructions, and inspection standards. Tackle special projects and cross-functional quality tasks as assigned. Qualifications Education & Background: Associate degree in an engineering, technical, or scientific discipline, or an equivalent mix of education and hands-on experience. Experience: Minimum of 2 years in quality assurance, product testing, or manufacturing operations (medical device industry strongly preferred). Regulatory Knowledge: Solid understanding of quality system regulations, specifically ISO 13485 or FDA 21 CFR Part 820. Technical Skills: Experience conducting test protocols, utilizing laboratory measurement tools, and working with basic data analysis tools (e.g., MS Excel). Quality & Detail Focus: Strong analytical mindset with rigorous attention to detail and record-keeping; ability to interpret technical drawings and schematics. Collaboration: Excellent interpersonal communication and cross-functional team skills. Bonus: Exposure to electronic Quality Management Systems (eQMS) software. Working Conditions Split between laboratory testing environments, production floor areas, and standard office spaces. Requires occasional lifting, extended periods of standing, and direct operation of test equipment. #J-18808-Ljbffr Aviso, LLC