Sr Quality Systems Engineer - CAPA (Maple Grove)

Sr Quality Systems Engineer - CAPA

The Sr Quality System Engineer will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Specifically, this role will support the Corrective and Preventive Action (CAPA) program at Maple Grove and ensure compliance to CAPA processes, Medical Device regulations and BSC Quality System requirements.

This is a hybrid work mode position located in Maple Grove, MN with the expectation to be in the office 3 days per week.

Your responsibilities include :

• Mentoring cross-functional CAPA teams on applying quality tools and techniques to identify root causes and create sustainable solutions to product and / or system issues.
• 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.
• Providing guidance to the CAPA team on activities, such as root cause analysis, corrective action plans and effectiveness verifications, and advising the team on applying sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic quality issues.
• Being a subject matter expert in matters relating to CAPA at the Maple Grove site with the ability to make sound decisions and provide guidance regarding 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, including influencing key stakeholders as appropriate.
• Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and / or projects.

Required Qualifications :

Preferred Qualifications :