Senior Design QA Engineer CAPA & NCEP Lead

Boston Scientific Corporation; Marlboro (MA); On-site; USD 82,000 - 156,000; Full time

Job summary

Boston Scientific Corporation is seeking a Design Quality Assurance Engineer III in Marlborough, MA to lead complex NCEP/CAPA activities across the product lifecycle. You will work with cross-functional teams to ensure safety, quality and regulatory compliance, and to drive continuous improvement of design controls and processes.

You will apply systematic problem-solving methods and coach others while acting as the voice for quality in projects, traveling 10–20% as needed.

Qualifications

• Requires a BS in Biomedical or Mechanical Engineering and 3+ years of medical device experience.
• Proven ability to own and lead CAPAs in the design environment.
• Knowledge of 21 CFR 820, EU MDR, EN ISO 13485 and EN ISO 14971 is preferred.

Responsibilities

• Lead complex design-related NCEP/CAPA activities across the product lifecycle.
• Apply Six Sigma and other root-cause analyses to diagnose issues and implement lasting corrective actions.
• Collaborate with cross-functional teams to create risk-appropriate CAPAs and design changes.
• Provide quality input to project teams on design reviews, V&V, usability testing, and labeling.

Skills

CAPA leadership

Root cause analysis

Design Controls

Six Sigma

Quality engineering

Risk management

Cross-functional collaboration

Communication

Education

BS in Biomedical or Mechanical Engineering

Tools

Minitab

Job description

Boston Scientific Corporation is seeking a Design Quality Assurance Engineer III in Marlborough, MA to lead complex NCEP/CAPA activities across the product lifecycle. You will work with cross-functional teams to ensure safety, quality and regulatory compliance, and to drive continuous improvement of design controls and processes.

You will apply systematic problem-solving methods and coach others while acting as the voice for quality in projects, traveling 10–20% as needed.