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.

• 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.

• 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.

• 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.

• 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.

• Safety is the highest priority; actively support the Environmental Health & Safety programs.
• Adhere to all Integer values.
• Achieve defined goals…