Manufacturing quality engineering

Quality Systems Engineer II

As a Quality Systems Engineer II, you will support the Corrective and Preventative Action (CAPA) process at Maple Grove, inclusive of nonconforming events.

The Quality Systems Engineer II will support compliance of the CAPA Process to internal requirements and external regulations. This includes CAPA Investigations and Product/Material/System Nonconformances. This role partners closely with Maple Grove CAPA team members, investigation owners, and site leadership. They will provide mentorship to Quality team members and cross-functional stakeholders to enable high-quality investigations, robust root cause identification, and sustainable corrective and preventive actions.

Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three 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.

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

Provide guidance on nonconformance investigations to support appropriate scoping, risk assessments, corrections, and material/product containment (including physical segregation/identification).
Provide 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
Apply 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
Partner with cross-functional stakeholders to drive standardization and adoption of best practices across sites
Team member of subject matter experts relating to CAPA at the Maple Grove site
Track actionable CAPA metrics and trends to ensure proper execution and effectiveness of the site CAPA program
Support Site, Regional, and Global CAPA initiatives, continuous improvement opportunities and/or projects
Drive continuous improvement and efficiencies to support a preventive quality culture

Bachelor's degree
Minimum of 2 years' experience in the medical device or pharmaceutical industry
Practical understanding of nonconformance and CAPA regulatory requirements and best practices
Experience leading or supporting cross-functional initiatives or projects
Strong problem-solving and root cause analysis skills
Ability to make sound, risk-based decisions

Minimum of 2 years' experience in Quality Systems and/or CAPA Management
Strong interpersonal skills with the ability to collaborate effectively across Quality, Manufacturing, Engineering, Regulatory, and Supply Chain functions
Ability to manage priorities in a fast-paced environment with strict regulatory timelines
Hands-on Project Management experience
Continuous improvement mindset with a passion for Quality

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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. Compensation for non-exempt (hourly), non-sales roles may 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).

annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

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.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.