Reports to the Post-Market Product Assurance (PMPA) manager. Performs typical post-market quality functions, such as investigation of individual product complaints, assisting with analysis of returned products, thorough root cause analysis, monitoring/trending field performance of assigned products, escalating identified trends, performing product risk analyses as needed, CAPA, and maintaining the risk management files associated with assigned products. Act as a liaison between the post-market quality organization located in Minneapolis and satellite manufacturing facilities in Mexico; therefore, candidate must be fluent in Spanish. Responsible for leading cross-functional teams responsible for the investigation and resolution of product quality issues.
• Ability to establish and maintain strong working relationships with satellite manufacturing facilities outside of the US. • Provides oversight of complaint investigation activities occurring at satellite manufacturing facilities. • Manages appropriate levels of interface with Regulatory Affairs, Clinical, Quality, Marketing, Operations and outside customers. • Effectively communicates project and work item status to key stakeholders. • Demonstrates excellent technical writing when authoring assigned Product Risk Assessment, Health Hazard Analyses, Post-Market Surveillance Reports, etc. • Demonstrates high level engineering thought processes and critical thinking. • Ability to apply sound engineering judgment and recommend solutions to complex issues. • Creatively and effectively challenges status quo when developing solutions. • Leads and/or supports failure mode investigations for product quality issues; performs deeper causal analyses on applicable customer complaints. • Leads and/or provides pertinent support to CAPAs as needed. • Facilitates PFMEA, DFMEA and Risk Management File updates on assigned product lines. • Leads and/or provides pertinent support to product quality meetings for assigned product lines to communicate field performance of products to cross-functional business partners. • May interface with internal or 3rd party auditors such as FDA, TUV, etc.
Bachelor’s Degree Engineering and 2 years of engineering experience.
Master’s Degree Engineering and 3 years of engineering experience (prefer medical device). Fluent in both Spanish and English. Proficient in the application of statistics, quality tools, and continuous process improvement methodologies. Thorough working knowledge of medical device industry product risk management regulations and standards. Understanding of heart anatomy.
Physical Job Requirements:
The employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Ability to move freely about the facility. Ability to sit / stand for extended periods of time. Travel: Approximately 10% (includes travel to satellite manufacturing facilities).