Quality Engineer II

Responsibilities The primary purpose of this position is to perform work which involves general engineering methods and tools. Utilize more advanced quality tools and concepts while developing as a quality engineer in the medical device industry. Apply engineering concepts to resolve acute or chronic problems. Ensure internal and external customer expectations are met or exceeded under guidance of more experienced engineers and managers. Adhere to all safety, environmental, security, and quality requirements, including QMS, SEMA, FDA regulations, company policies, and other regulatory requirements. Support regulatory and agency inspections, audits, investigations, and inquiries concerning product design and manufacturing quality. Monitor manufacturing of assigned products, ensuring compliance with DMR, providing deviation/waiver guidance, and maintaining complete and correct Device History Records. Review the adequacy and correctness of changes to Bill of Materials (BOM), Assembly Procedures, Drawings, Component Specifications, FMEAs, and Control Plans. Participate in continuous improvement projects and assist with product transfers. Perform technical projects following the standard quality management and production system methodologies to investigate opportunities for product and process improvements. Collaborate with others, exchanging information, asking questions, and regularly checking for understanding to support professional development. Lead the generation and completion of protocols and reports for test method validations. Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where applicable. Develop inspection techniques and procedures to ensure product integrity to design specifications. Write, approve, and implement Incoming, In‑Process, and Final Inspection procedures. Ensure disposition of non‑conforming materials meets all required procedures and that corrective actions are adequate to prevent recurrence. Lead and manage complaint investigations. Participate in plant CAPA activities, analyze data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root‑cause analysis. Apply standard data analysis practices, observe products and processes to establish root causes of failures or support justification for improvements. Support internal quality audit activities as applicable. Own quality by ensuring adherence to the Quality Management System, supporting corrective and preventive action investigations and implementation, and contributing to quality KPIs. Perform other duties as needed and as directed by line of supervision. Support Integer’s Manufacturing Excellence and Market‑Focused Innovation Strategies, including alignment through Site Hoshin Plans, Quality Plans, Validation master plans, and regular updates to QA RA metrics. Lead sustained change efforts, ensuring customer change notifications are initiated and completed and supporting continuous improvement activities. Standardize workplace organization, visual controls (5S), Manufacturing Standard Work, and robust training and certification programs where applicable. Promote associate engagement through standardized problem‑solving methodologies, behavior‑based safety programs, and improvement idea and suggestion systems. Drive systems and process optimization through adoption of built‑in‑quality principles. Qualifications Minimum education: Bachelor’s degree in engineering or a related field and 3 years of relevant experience; candidates without the education requirement may be considered with 7+ years of experience. Specialized knowledge of relevant domestic and international regulations and industry standards (e.g., ISO, QSR, UL, MDD, TGA). Knowledge of Microsoft Office applications. Demonstrate a solid technical aptitude and the ability to be an effective contributor to a team or produce results independently. Strong written and oral communication competencies. For applicants outside the U.S., demonstrate competencies in both written and oral English communications. Maintain a calm demeanor in a high‑energy, constantly changing production environment. Possess a positive, can‑do attitude with a belief that failure is not an option. Benefits and Compensation Salary range: $71,250 – $104,500. Competitive base salary and cash‑based incentive program. Medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave available after one year of employment. Optional employee‑paid programs: supplemental life insurance, critical illness, hospital indemnity, and accident insurance. Immediate eligibility for a 401(k) plan with company matching contributions. 80 hours (10 days) of company designated holidays per year plus paid time off. Comprehensive benefits package with immediate eligibility. EEO Statement Integer Holdings Corporation is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, disability, veteran status, or any other protected characteristic. All employment decisions are based on job requirements, skill, and performance. Integer provides reasonable accommodations for qualified applicants and employees with medical or religious needs. For accommodation requests, contact +716-759-5631 or View email address on click.appcast.io. #J-18808-Ljbffr Integer Holdings Corporation