Quality Systems Engineer II

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.

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. Here, you’ll be supported in progressing – whatever your ambitions.

About the role :

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.

Your responsibilities include :

• 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

What we're looking for in you :

Required qualifications :

Preferred qualifications :

Requisition ID : 597130

Minimum Salary : $67500

Maximum Salary : $128200

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and / or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.

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Salary : $67,500 - $128,200