Boston Scientific Quality Systems Engineer II 

United States, Minnesota, Maple Grove 

448220661

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:

• Bachelor's degree
• 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

Preferred qualifications:

• 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
  

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.