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Salary: USD 85,000 - 161,500 / annual
Boston Scientific is seeking a Senior Quality Engineer to support its Cardiac Diagnostics business unit. This role provides critical quality engineering leadership, ensuring the highest quality standards across products, services, and processes. You will lead quality initiatives centered on continuous improvement and organizational compliance, partnering closely with cross-functional product development, supplier, and production teams.
Key responsibilities include:
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
- Lead and coordinate Corrective and Preventive Actions (CAPA) processes, including investigational meetings, determinations, activity tracking, and record closures
- Evaluate system adequacy and compliance against regulations and company documentation
- Collaborate with technicians and engineers on dispositioning non-conforming material and identifying manufacturing process defects
- Advise, review, and approve process validation and verification activities
- Collect and analyze process defect data for product and process improvement efforts
- Support regulatory submissions to notified bodies
- Mentor and train team members on quality engineering best practices
- Maintain commitment to patient safety and product quality through compliance with Quality Policy and documented procedures
This is a high-visibility role in a fast-paced, high-growth environment where you will interface with multi-disciplined teams at all levels, provide quality leadership, and drive solutions for complex problems.
REQUIREMENTS:
Required:
- Bachelor's degree in engineering or related discipline
- 5+ years of relevant quality engineering experience (or 3+ years with a relevant master's degree)
- Knowledge of Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards
- CAPA experience including leading root cause investigations, implementing corrective actions, and verifying effectiveness
- Familiarity with medical device risk management activities and their connection to organizational processes
- Familiarity with quality tools and problem-solving techniques
- Experience in the medical device industry
Preferred:
- Prior interactions with software and hardware development, manufacturing engineering, post-market complaints, risk management, supplier quality, and process engineering
- Experience with MS Office applications and PLM (Windchill)
- 2+ years' experience in validation, statistical sampling, and/or root cause investigation
- Familiarity with QMS documentation (DHF, DMR, DHR, SOPs, WIs, FMEAs, quality records)
- Problem-solving certification (CQE, Six Sigma, etc.)
- Demonstrated program/project management skills
- Critical thinking, active listening, and strong time management
- Self-starter mentality with ability to quickly learn new processes
- Excellent analytical and written/oral communication skills
