Post Market Surveillance Engineer II

What you’ll do in this role: Execute and support the Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes under guidance from experienced associates and managers. Provide support in the analysis, evaluation, and product investigation of complaints received from external customers in a timely manner to comply with FDA 21 CFR (QSR) requirements and other regulatory requirements. Adhere to Integer’s values and all safety, environmental, security and quality requirements including QMS, Safety, Environmental and Security Management Systems, FDA regulations, company policies, and other regulatory requirements. Post Market Complaint Handling Activities: Accurately capture and document all complaints in the complaint handling database according to internal policies. Send complaint acknowledgements to customers. Track customer return products. Perform complaint investigation activities with cross‑functional team members. Review device history records for nonconformities related to the alleged complaint. Interface with internal and external customers to gather additional information for investigations and prepare customer communication, investigation reports, and Customer Facing Reports. Execute data collection, root cause investigations, and resolution in support of a thorough complaint investigation related to product quality and patient safety. Play an active role in ensuring timely closure of investigations to comply with FDA and other regulatory requirements. Handle, decontaminate, and analyze products used in the field by hospitals/end users per internal procedures and safety requirements (requires relevant vaccinations). Perform risk assessments for products that are Integer owned designs. Perform CAPA assessments and support CAPA investigations. Assess Adverse Event Reportability decisions in accordance with U.S. and International regulations. Assist in the completion of applicable forms for submission of reportable complaints to applicable agencies. Assist in gathering complaint and ship data to support Post Market Trending, PMSRs, and PSURs. Collaborate with others to exchange information, ask questions and regularly check for understanding in support of your development as a Post Market Surveillance Engineer II. Audit Support: Support internal and external audits, provide support for regulatory inspections and customer audits, and assist in the timely response and closure of audit observations and findings. Quality System Responsibilities: Work on projects following Integer's standard quality management system methodologies to investigate opportunities for process improvement. Collaborate with others, ask questions, and regularly check for understanding in support of development as an Associate Product Surveillance Engineer. Embed quality within the Regulatory discipline, ensuring adherence to QMS, facilitating or contributing to corrective and preventive actions, and contributing to the successful attainment of quality KPIs and progress toward 5 Sigma. Perform other duties as needed and directed by line of supervision. Manufacturing Excellence Imperatives: Provide support of Integer's Manufacturing Excellence and Market Focused Innovation Strategies. Participate or lead in site Hoshin Planning, Quality Planning, Validation master plans and associated quality improvement imperatives. Provide leadership as required for QA/RA weekly and monthly metrics, supporting the walk to 5 Sigma. Lead sustained change to ensure customer change notifications are initiated and completed as necessary, and support continuous improvement activities. Support the standardization of workplace organization (5S), manufacturing standard work, and robust training and certification programs where applicable. Promote associate engagement through standardized problem‑solving methodologies, behaviour‑based safety programs, and improvement idea and suggestion systems. Support system and process optimization through the adoption of built‑in quality principles. How you will be measured: Safety is the highest priority; actively support the Environmental Health & Safety programs. Adhere to all Integer values. Achieve defined goals and objectives specifying key projects and milestones. Achieve site quality KPIs and innovation/ideation key metrics, including continuous improvement suggestions. What sets you apart: Minimum education: bachelor’s degree and at least 1 year of relevant experience; or 3 years of experience if education requirement is not met (medical device or other regulated industry preferred). Demonstrate ability to work independently and collaboratively with cross‑functional teams. Show solid technical aptitude and effective teamwork or individual results. Demonstrate written and oral communication competencies. Be highly organized, able to manage multiple projects and complaints simultaneously. Possess intermediate to advanced skills in Microsoft Office (PowerPoint, Visio, Project, Excel, Word). Maintain a positive, can‑do attitude with the belief that failure is not an option. Our total rewards program includes a base salary, cash‑based incentive program, comprehensive benefits (medical, dental, vision, disability, life insurance, adoption benefits), parental leave after one year, optional supplemental insurance, 401(k) with company matching, and 80 hours (10 days) of company‑designated holidays plus paid time off. U.S. Applicants: Equal Opportunity Employer. Veterans and individuals with disabilities are encouraged to apply. #J-18808-Ljbffr Integer Holdings Corporation