Quality Supervisor - Interventional Cardiology & Vascular Therapies (ICVT) Post Market CIS

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Quality Supervisor - Interventional Cardiology & Vascular Therapies (ICVT) Post Market CIS

Work mode: Onsite Onsite Location(s): Arden Hills, MN, US, 55112 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career.

About This Role: Responsible for leading a team of quality personnel and providing technical acumen and leadership to the Interventional Cardiology & Vascular Therapies (ICVT) Post Market Complaint Investigation Site (CIS) that directly supports complaint product investigations ranging from Single Use Devices to Capital Equipment and accessories. This role oversees day to day operations of the complaints investigation team, ensures products are investigated in compliance with applicable internal procedures and regulatory requirements, and partners with leadership and other functions to improve rates of actionable outcomes of product investigations. Will identify, coordinate, and execute project priorities based on business and department objectives and, at times, the Global BSC level. Responsible for identifying and implementing continuous improvements to product performance and complaint processes. This role provides significant visibility across site and divisional leadership.

Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five (5) days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your Responsibilities Will Include: Lead, coach and develop a team of quality technicians by providing training, technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques, performance feedback and career development opportunities. Support staffing activities, including interviewing, hiring and onboarding new employees. Conduct performance evaluations and address employee performance issues in accordance with company policies and procedures. Utilize data analysis to oversee effective execution of complaint management WIP and metrics enhancement and reporting Analyzing customer complaints, events and other post market surveillance data by examining the data for patterns and trends and investigating when necessary. Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes are effectively implemented while still meeting organizational and regulatory requirements. Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization. Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations. Fostering a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Demonstrating a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

What We're Looking For In You: Required Qualifications Bachelor's degree with an Engineering or Science background with 4+ years of relevant experience (3+ years with Master's degree) Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards Preferred Qualifications Experience in Medical Device industry, as well as Post Market specific activities Demonstrated problem-solving & data analysis capabilities Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook Strong business acumen and communication skills, with the ability to quickly establish impact and consequences Ability to collaborate and influence across multiple, cross-functional teams Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis

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