Senior Quality Engineer, Cardiac Diagnostics CAPA Leader

Boston Scientific; Arden Hills (MN); On-site; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Senior Quality Engineer to provide critical quality support for Cardiac Diagnostics. The role leads CAPA activities, problem solving, and cross-functional collaboration to improve device quality, processes, and compliance.

The candidate will interact with product development, supplier, and production teams, champion risk management and verification activities, and mentor teams in quality discipline adoption.

Qualifications

• Bachelor’s degree in engineering or related discipline.
• 5 or more years of relevant quality engineering experience (3 or years with a relevant master's degree).
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.
• CAPA experience including leading root cause investigations, implementation of corrective actions and verification of effectiveness
• Familiar with medical device risk management activities and their connection to organizational processes
• Familiar with quality tools and problem-solving techniques

Responsibilities

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Act as an effective leader and team member in supporting quality disciplines, decisions, and practices.
• With input from organizational stake holders organize, schedule, and conduct investigational and problem resolution meetings with cross-functional team members to coordinate, contribute to and document NCEP/CAPA processes including determinations, activity tracking, and record closures.
• Evaluate the adequacy and compliance of systems and practices against regulations and company documentation.
• Participate in team decision making and display team problem solving/communication skills.
• Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
• Collaborate with technicians and engineers in dispositioning non-conforming material, assisting in identification of manufacturing process defects, identification of primary root causes, and understanding corrective and preventative actions.
• May be responsible for working with process owners, suppliers, and other internal groups
• Advise, review and approve process validation and verification activities that support corrective actions.
• Collect and analyze process defect data for product/process improvement efforts (e.g., nonconforming product, failure analysis, customer complaints, etc.)
• Support NCEP/CAPA activities as Subject Mater Expert, mentor, and trainer.
• Support regulatory submissions to notified bodies.

Skills

Quality engineering

CAPA

Root cause analysis

Problem solving

Regulatory awareness

Education

Bachelor’s degree in engineering or related discipline

Master’s degree in related field (advantage)

Tools

Windchill

MS Office

Job description

Boston Scientific is seeking a Senior Quality Engineer to provide critical quality support for Cardiac Diagnostics. The role leads CAPA activities, problem solving, and cross-functional collaboration to improve device quality, processes, and compliance.

The candidate will interact with product development, supplier, and production teams, champion risk management and verification activities, and mentor teams in quality discipline adoption.