Quality Engineer II

What you’ll do in this role: The primary purpose of this position is to perform work which involves general engineering methods and tools. You will now be utilizing more advanced quality tools and concepts while developing your role as a quality engineer in the medical device industry. You apply engineering concepts to resolve acute or chronic problems. You will ensure Integer internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization. You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. Manufacturing Support: You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. You will monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained. You will review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. You will participate in continuous improvement projects. You will assist with product transfers. You will perform work on technical projects where you will follow Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements. Collaborate with others in the exchange of information, ask questions, and regularly check for understanding in support of your development as an engineer. Create Test Methods: You will lead the generation and completion of protocols and reports for test method validations. You will interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable. You will develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval, and implementation of Incoming, In-Process and Final Inspection procedures. Support Non‑Conforming Material Process: You will ensure that the disposition of non‑conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re‑occurrence. You will lead and manage complaint investigations. You will participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. You will apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or to support the justification for improvements to products and processes. Support Site Quality Activities: You will support internal quality audit activities, as applicable. You embed Quality—"I own Quality." You are a standard bearer for Quality in everything we do at Integer, by ensuring adherence to our Quality Management System (QMS), supporting corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPIs and journey to differentiated quality. You may perform other duties as needed and as directed by your line of supervision. Qualifications Minimum Education: At a minimum you have earned a bachelor’s degree in an engineering or related field and 3 years relevant experience. Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience. Specialized Knowledge: You will have awareness of relevant Domestic and International Regulations and Industry Standards (e.g., ISO, QSR, UL, MDD, TGA, etc.) You will have good knowledge in Microsoft Office while you will demonstrate ability to work independently as well as collaboratively with other associates and cross‑functional teams. Specialized Skills: You will demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual. You will demonstrate competencies in both written and oral communications. For outside of US countries, you will demonstrate competencies in both written and oral English communications. You will maintain a calm demeanor that transcends the high energy, constantly changing production environment. You will possess a positive, can‑do attitude with an underlying belief that failure is not an option. Salary Range $71,250 - $104,500 Equal Opportunity Employer Integer is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and other protected characteristics. Integer celebrates differences and remains committed to providing an inclusive workplace free from harassment and discrimination. Integer does not discriminate against applicants or employees who are disabled veterans, Armed Forces service medal veterans, recently separated veterans, or active‑duty wartime veterans, campaign badge veterans, and individuals with disabilities. All employment decisions are based only on valid job requirements. Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. #J-18808-Ljbffr Integer Holdings Corporation