Quality Systems Engineer II

Boston Scientific - Maple Grove, MN

Hybrid - Maple Grove, MN

Merchant Wholesalers, Durable Goods

About the position

The focus of this Quality Systems Engineer II position will be supporting the Corrective and Preventive Action (CAPA) process at Maple Grove, including nonconforming events, and ensuring compliance to CAPA processes, Medical Device regulations, and BSC Quality System requirements. As a member of the Quality Systems team, this individual will support department, site, and global level initiatives and will maintain a strong collaborative partnership with multi-functional teams while contributing to the overall health, including the suitability, adequacy, and effectiveness, of the CAPA process. This is a hybrid work mode position located in Maple Grove, MN with the expectation to be in the office 3 days per week.

Responsibilities

• Mentoring cross-functional CAPA teams on root cause analysis, corrective action plans, and effectiveness verifications.
• Using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables, and meet critical CAPA phase timelines.
• Creating robust, compliant, and timely records, using the electronic CAPA database system.
• Providing continuous and rigorous assessment of CAPA activities and review of documentation throughout the CAPA lifecycle to ensure compliance with global BSC CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements.
• Applying sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic quality issues.
• Acts as an effective team member and/or leader in supporting quality disciplines, decisions, and practices.
• Being part of a team of subject matter experts in matters relating to CAPA at the Maple Grove site and providing guidance on how to best apply the processes efficiently, effectively, and compliantly.
• Determining and tracking actionable CAPA metrics and trends to ensure proper execution and effectiveness of the site CAPA program.
• Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects.

Requirements

• Bachelor's degree and 2+ years of experience in a medical device manufacturing setting, within quality or regulatory/compliance environment.
• Knowledge of basic Quality System Requirements and Good Documentation Practices.
• Experience working with nonconforming material and/or CAPA methodologies/systems.
• Attention to detail, strong technical writing and documentation skills, and the ability to prioritize tasks effectively in a deadline-driven environment.
• Strong communication skills (written and verbal), e.g. comfortable speaking and presenting to different levels of management and cross-functional stakeholders.

Nice-to-haves

• Bachelor's Degree(s) in Science or Engineering.
• 2+ years of experience in Quality Systems and/or CAPA management.
• Detailed understanding of quality system requirements as stated within FDA Quality System Regulation 21 CFR Part 820 and ISO 13485.
• Hands-on Project Management experience.
• Able to work independently and as a contributing team member.
• Continuous improvement mindset with a passion for Quality.