Senior Quality Systems Engineer: CAPA & Regulatory Readiness

Nalu Medical; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific in Arden Hills, MN seeks a Senior Quality Systems Engineer to lead or support complex quality system initiatives, directing cross-functional remediation and CAPA efforts. The role partners with Quality, Regulatory, Manufacturing, Operations, R&D, Supply Chain and leadership to ensure compliance and continuous improvement.

The successful candidate will manage regulatory inspections, drive process improvements, and oversee metrics while navigating a highly regulated medical

Qualifications

• Bachelor's in Engineering/Science/Quality with 5+ years, or Master's with 3 years.
• Experience leading complex Quality System projects across functions.
• Knowledge of 21 CFR 820, ISO 13485, EU MDR, MDSAP, ISO 14971.
• CAPA systems, quality investigations, audit processes, regulatory inspections.
• Strong project management, communication, stakeholder management.
• Ability to work independently and influence without authority.

Responsibilities

• Lead or support complex Quality System compliance initiatives and cross-functional remediation projects across the Arden Hills site.
• Serve as a Quality Systems subject matter expert for complex compliance issues, regulatory expectations and Quality System implementation.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve complex Quality System issues.
• Lead and support CAPA system activities, including investigation quality, effectiveness reviews, documentation improvements, aging reduction initiatives and cross-functional execution.
• Assist with the development and maintenance of department metrics and management systems, as needed.
• Act as an effective leader and collaborative team member in Quality System activities supporting strategic compliance initiatives, goals and objectives.
• Support external audits through preparation, execution, coordination, evidence collection, response development and closure activities for regulatory inspections and third-party audits.
• Partner with Quality System process owners to identify compliance gaps and implement sustainable corrective actions.
• Support organizational readiness for regulatory inspections through proactive assessments, coaching and continuous improvement activities.
• Identify opportunities to simplify, standardize and improve Quality System processes while maintaining compliance.
• Promote a work environment that supports the Global Quality Policy, Global Quality System, continuous improvement and Winning Spirit.

Skills

Project management

Quality Systems

Regulatory knowledge

CAPA

Leadership

Cross-functional

Communication

Audit readiness

Education

Bachelor's degree

Master's degree

Tools

CAPA system

Job description

Boston Scientific in Arden Hills, MN seeks a Senior Quality Systems Engineer to lead or support complex quality system initiatives, directing cross-functional remediation and CAPA efforts. The role partners with Quality, Regulatory, Manufacturing, Operations, R&D, Supply Chain and leadership to ensure compliance and continuous improvement.

The successful candidate will manage regulatory inspections, drive process improvements, and oversee metrics while navigating a highly regulated medical