Post Market Surveillance Engineer II

What You’ll Do in This Role The primary purpose of this job is to execute and support the Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes for the company under direction from more experienced associates and managers. The role requires supporting analysis, evaluation, and product investigation of complaints received from external customers in a timely manner to comply with FDA 21 CFR (QSR) and other regulatory requirements. Accurately capture and document all complaints in the complaint handling database. 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 alleged complaints. 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 supporting thorough complaint investigations related to product quality and patient safety. Ensure timely closure of complaint investigations to meet FDA and other regulatory bodies’ requirements. Handle, decontaminate, and analyze field‑used products per internal procedures, requiring relevant vaccinations. Perform risk assessments for company‑owned product designs. Perform CAPA assessments and support CAPA investigations. Assess adverse event reportability decisions per U.S. and international regulations. Assist in completing applicable forms for submission of reportable complaints to agencies. Gather complaint and ship data to support post‑market trending, PMSRs, and PSURs. Audit Support Support internal and external audits. Provide support for external regulatory inspections and customer audits. Respond to and close audit observations and findings promptly. Quality System Responsibilities Work on projects utilizing the company’s quality management system methodologies to investigate opportunities for process improvements. Ensure adherence to the Quality Management System (QMS), safety, environmental, and security management systems, FDA regulations, company policies, and operational procedures. Facilitate and/or contribute to corrective and preventive actions. Contribute to achieving quality key performance indicators and the organization’s journey to 5 Sigma. Manufacturing Excellence Imperatives Support manufacturing excellence and market‑focused innovation strategies. Participate or lead site Hoshin planning, quality planning, validation master plans, and associated quality improvement imperatives. Lead QA/RA weekly and monthly metrics and support the walk to 5 Sigma. Ensure customer change notifications are initiated and completed, supporting continuous improvement. Support workplace organization, visual controls (5S), manufacturing standard work, and training & certification programs. Measurement & Expectations Safety is the highest priority; the role requires active support of environmental, health, and safety programs. Success will be measured by achieving site quality KPIs; innovation and ideation are critical aspects, and the employee will generate continuous improvement suggestions and support their implementation. Qualifications Minimum education: Bachelor’s degree with at least 1 year of relevant experience, or 3 years of relevant experience if education requirement not met. Experience in medical devices or regulated industries is preferred. Ability to work independently and collaboratively across cross‑functional teams. Solid technical aptitude and effective communication skills. Highly organized with ability to track multiple projects and complaints simultaneously. Intermediate to advanced skills in Microsoft Office (PowerPoint, Visio, Project, Excel, Word). Positive, can‑do attitude with a belief that failure is not an option. Benefits Base salary and cash‑based incentive program. Medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave available after one year. Optional employee‑paid programs: supplemental life insurance, critical illness, hospital indemnity, and accident insurance. Immediate participation in a 401(k) plan with company matching. 80 hours (10 days) of company‑designated holidays per year plus annual paid time off. Equal Opportunity Employer The company is an equal opportunity employer. The company does not discriminate based on race, color, sex, religion, national origin, or any other protected characteristic. The company encourages veterans and individuals with disabilities to apply. The company will provide reasonable accommodations to qualified job applicants and associates with medical or religious needs. #J-18808-Ljbffr