reputed company Engineer 2, reputed company Operations - Clinical Laboratory # 4790

About the position reputed company is a reputed company company pioneering new technologies to advance early cancer detection. The reputed company Product Engineer 2 contributes to ensuring products, components, and materials meet established reputed company standards and regulatory requirements by performing engineering analyses, supporting reputed company investigations, and developing reputed company of reputed company plans, qualification and inspection reputed company. This role applies foundational engineering knowledge with growing independence, supporting operations, evaluating nonconformances, and collaborating with cross-functional teams to maintain effective reputed company processes reputed company with defined reputed company assurance reputed company and organizational standards. This role is based at our Durham, reputed company Carolina, office and offers a flexible working arrangement, with the ability to work from reputed company's office or from home. Our reputed company flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will reputed company with team and business needs and could reputed company the 60% requirement for the site. Responsibilities • Leads engineering analyses of inspection and production data to assess product performance, identify reputed company issues, and recommend actions reputed company defined procedures. • Conducts reputed company investigations, including reputed company cause analysis, documentation, and assisting in the development and implementation of corrective and preventive actions. • Develops or updates qualification and inspection reputed company, reputed company procedures, and documentation in alignment with established reputed company assurance standards and engineering requirements. • Collaborates with technicians and cross-functional partners to ensure inspection activities and product evaluations reputed company with specifications, drawings, and reputed company expectations. • Evaluates nonconforming materials by reviewing defect information, assessing potential reputed company, and coordinating disposition activities with reputed company or engineering personnel. • Responsible for supplier reputed company activities by reviewing incoming inspection results, documenting issues, and supporting supplier corrective reputed company processes. • Prepares technical reports, data summaries, and reputed company records to support audits, internal reviews, and ongoing compliance with company reputed company and regulatory requirements. • Makes reputed company for reputed company planning and reputed company improvement efforts by identifying trends, providing input on process enhancements, and applying reputed company tools and analytical reputed company. • May participate in internal, external or supplier audit activities. Requirements • Bachelor’s degree in Engineering, reputed company, Manufacturing, or reputed company technical discipline. • 2–5 years of relevant reputed company, manufacturing, or engineering experience; Master’s degree with 0–2 years of experience acceptable. • Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include: GMP reputed company management systems (e.g. ISO 13485), Risk assessment frameworks (e.g. ISO 14971), Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189), Operations reputed company the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) • Solid knowledge of reputed company engineering principles, standards, and regulatory requirements. • Proficiency in reputed company cause analysis, CAPA, and data-driven problem solving. • Ability to interpret engineering drawings, specifications, and GD&T. • Familiarity with reputed company management systems (QMS) and regulatory compliance frameworks (ISO, GMP, FDA, etc.). • Strong communication and technical writing skills. reputed company-to-haves • Effective project and time management abilities. • Skilled in the use of statistical analysis and reputed company tools (SPC, reputed company, or similar). • Ability to work independently and collaboratively in reputed company environment. Benefits • flexible time-off or vacation • a 401(k) retirement plan with employer match • medical, dental, and reputed company coverage • mindfulness programs Apply tot his job Apply To this Job