Quality Systems Engineer II - CAPA

Recruiter: Spencer Gregory Hale

Quality Systems Engineer II

About the role:

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.

Your responsibilities will include:

• Mentor 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

• 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

Qualifications:

Required qualifications:

• 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
• Understanding of regulations/standards such as 21 CFR 820 and ISO 13485
• Experience leading or supporting cross-functional initiatives or projects
• Strong problem-solving and root cause analysis skills
• Strong communication and stakeholder management skills
• Ability to make sound, risk-based decisions

Preferred qualifications:

• 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
• High attention to detail, organizational skills, and a disciplined approach to compliance and documentation
• Ability to prioritize tasks effectively in a deadline-driven environment
• Proactive problem solver with a continuous improvement mindset
• Ability to manage priorities in a fast-paced environment with strict regulatory timelines
• Hands-on Project Management experience
• Able to work independently and as a contributing team member
• Continuous improvement mindset with a passion for Quality

Requisition ID: 634838

Minimum Salary: $ 71500

Maximum Salary: $ 135800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—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. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

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).

Compensation for exempt, non-sales roles may 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.

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. 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.