Quality Engineer

Company Overview Hamilton Medical was founded in 1983 with a clear mission: to enhance the lives of patients on respirators and support the caregivers who serve them. Our focus is on developing ventilation technologies that prioritize safety, effectiveness, and lung protection. We are dedicated to easing the burden on healthcare professionals who work tirelessly every day, helping critically ill patients recover and regain their health. We are committed to helping medical teams deliver the best respiratory care - to anyone, anywhere. Responsibilities Ensures compliance to existing procedures and regulations through document review, audits and facilitation of risk management, data trending and root cause analysis. Analyzes production limitations and problems and facilitates root cause analysis. Analyzes data to bring conclusion to production and quality management. Reviews change orders for product releases/updates and production material and process changes. Conducts and documents internal non-conformance and customer complaint investigations. Support in Medical Device reporting (MDRs), complaints, field corrective action (Recall) and management review meeting. Effectively engage in project as the Quality Engineering resource. Formulates or assists in formulating quality standards, policies, programs, plans, procedures, and practices. Assesses and approves product and process validation activities. Performs such individual assignments as supervisors and superiors may direct. Ensures adequate and continuous controls are exercised over all assigned activities affecting quality. Establishes and maintains effective work relationships. Maintains the professional competence, knowledge, and skill necessary for the satisfactory performance of all assigned responsibilities. Facilitates the completion of Risk Analysis documentation for new and existing products/processes. Organize and conduct internal and supplier audits. Initiates and manages Corrective/Preventative actions based on data review and input from outside sources and internal data analytics. Serves as quality contact during customer and notified body audits. Qualifications Able to read and understand engineering design drawings, technical plans, and reports. Possess knowledge and hands‑on experience with ISO quality system standards ISO 13485, ISO 14971, and FDA 21 CFR 820. Auditing education and experience. Ability to work effectively with various work groups to assure conformance to quality and regulatory requirements, internal processes and policies. Ability to prioritize tasks in deadline driven environment. Strong written and verbal communication and organizational skills. Education / Experience Bachelor's Degree in Mechanical Engineering, Manufacturing Technology, Business, or related discipline from an accredited university. Minimum of 3 years of quality assurance experience. Certification in Quality (CQE, CSSBB, CQA) a plus. About Hamilton Diverse portfolio of exciting and innovative design projects. Tremendous opportunities for professional growth and advancement. Commitment to sustainable design. Competitive Compensation. Excellent Benefit Package (medical, dental, vision insurance, paid time off, disability insurance, 401k, tuition reimbursement and much more). Solid Stable Company. Drug free workplace. #J-18808-Ljbffr