Quality Engineer

Quality Engineer

This quality engineer role will investigate product complaints and monitor BSC product performance. The team uses product performance data and deep dive analysis to understand if products are performing as intended. Escalating post-market field performance signals to better understand what the data is telling us, collaborating with cross-functional teams to mitigate risk, focusing on patient safety, and improving product performance. Client-related assignment

Your responsibilities may include: embodying BSC's core values of caring, meaningful innovation, high performance, global collaboration, diversity, winning spirit; reviewing completed returned product lab analysis, customer feedback, and historical data to identify proper coding for product complaints; performing complaint investigations in accordance with local and global processes; analyzing post-market surveillance data for patterns and trends and investigating when necessary; responding to competent authority requests;

communicating product performance by formal presentations to management committees and design teams, supporting published product performance reports and customer requests for performance information either directly or through the sales organization; providing input for process improvement and helping develop tactical approaches to implement team strategies; performing data analysis for product performance and risk management documentation by applying statistical methods and software;

engaging in projects/project plans outlining work plans including timelines, roles and resources; identifying and leading cross-functional project teams comprised of functional experts and local managers; being open and flexible to change in responsibilities, taking on new engineering tasks and new product lines as the department grows and evolves; fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives;

investigating and reviewing electronic circuits and components; analyzing returned products to address complaints; assisting lab technicians during complaint investigations to ensure accurate and compliant product analysis and documentation; and reviewing completed product analysis to ensure field allegations are adequately addressed.

Minimum qualifications include a bachelor's degree or higher in electrical or biomedical engineering, BS with 1-3 years of relevant experience, a strong desire to be a part of a team that looks to make a difference each day to collectively solve problems, understanding and a command of highly technical engineering topics and applied statistics, ability to independently manage project work to define and consistently meet delivery dates, understanding and experience operating within quality system processes and procedures, and strengths in communication (verbal and written) and data analysis skills.

Preferred qualifications include an engineering degree with 2-3 years of relevant medical device experience, experience in physical device analysis, strong technical understanding of medical device therapy products, significant participation in the hazard analysis and risk assessment as related to trend management, strong technical writing skills, experience with quality system escalations, CAPA investigations and field assessments, strong understanding of the medical device regulatory requirements of post-market complaint tracking, trending, and analysis, project experience and/or collaboration with medical safety, design assurance, return product analysis, supplier development and manufacturing.