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 Integer under the direction, instruction and guidance from more experienced associates and managers. This position will be responsible for executing and providing 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 requirements of other regulatory bodies and countries.

Post Market Complaint Handling Activities

• Accurately capture and document all complaints in the complaint handling database according to internal policies and procedures
• 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 required for complaint investigations and prepare customer communication, complaint 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
• Ensure timely closure of complaint investigations to comply with requirements of FDA and other regulatory bodies and countries
• Handle, decontaminate, and analyze products used in the field by hospitals/end users per internal procedures and safety requirements
• 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 US 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

Audit Support

• Support internal and external audits
• Provide support for external regulatory inspections and customer audits
• Support the timely response and closure of audit observations and findings

Quality System Responsibilities

• Perform work on projects following Integer's standard quality management system methodologies to investigate opportunities for process improvements
• Embed Quality within the Regulatory discipline
• Assure adherence to the Quality Management System (QMS), facilitate and/or contribute to corrective and preventive actions, and contribute to the successful attainment of quality KPIs and journey to 5 Sigma

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 ensuring customer change notifications are initiated and completed, and support continuous improvement activities
• Support the standardisation of workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs
• Promote Associate Engagement through standardized problem solving methodologies, behaviour-based safety programs, and improvement idea and suggestion systems
• Support Systems & Process Optimization through adoption of principles of built in quality

What sets you apart

Minimum Education and Experience: You have earned, as a minimum, a bachelor's degree and have at least 1 year of relevant experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 3 years' relevant experience (medical device or other regulated industry experience preferred).

Specialized Knowledge: You will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.

Specialized Skills: You 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 demonstrate competencies in both written and oral communications. You are highly organized and able to work and track multiple projects and complaints simultaneously. You possess intermediate to advanced skills using Microsoft Office (PowerPoint, Visio, Project, Excel, Word, etc.). You possess a positive, can-do attitude with an underlying belief that failure is not an option.