Summary As a Quality Engineer, you will play a key role in enhancing the quality of our products and processes within a culture that values integrity and doing the right thing. You will support and guide adherence to established processes and procedures to ensure the safety, efficacy, and quality of our products, while maintaining compliance with applicable standards and regulations.Duties and Responsibilities Manage processes and projects of moderate to high complexity, performing compliance assessments and making informed decisions regarding quality and regulatory requirements. Ensure adherence to current regulations and quality standards. Participate in projects focused on quality initiatives and compliance improvements. Author and revise operating procedures, test protocols, inspection protocols, and reports. Conduct impact assessments, root cause analysis, and identify and implement corrective and preventive actions (CAPA). Perform statistical analysis and trend reporting to support site initiatives (., yield improvements, CAPA, complaint reduction, scrap reduction). Contribute to continuous process improvement through active participation in site projects. Facilitate risk assessments and Failure Modes and Effects Analyses (FMEAs) for new product introductions. Implement appropriate quality controls to mitigate product, safety, and business risks. Create, maintain, and remediate Design History Files and Risk Management Files. Perform Supplier Change Evaluations, Internal Change Evaluations, Product Quality Reviews, Customer Notifications, and Field Action activities. Participate in new product development activities to ensure smooth transfer from development to production. Support additional activities within the Quality Management System as required. Perform other duties as assigned. Preferred Qualifications Working knowledge of industry standards such as ISO 13485, ISO 14971, ISO 11135, ISO 60601, etc. Ability to work independently and collaboratively in a team environment. Self-motivated, adaptable, and proactive. Excellent verbal and written communication skills. Strong attention to detail. Education and Experience Bachelor’s degree in an engineering discipline from an accredited college or university. Minimum of four (4) years of experience in the medical device industry or another highly regulated field, or an equivalent combination of education and experience. Knowledge, Skills, and Abilities In-depth knowledge of ISO 13485 and ISO 14971 (minimum requirement). Familiarity with FDA 21 CFR Part 820. Understanding of EU MDD/MDR and other relevant international directives and regulations. #IND1