Senior Quality Engineer - Cardiac Diagnostics (CDx) at BScientific

Department: Quality Assurance, Reliability

Compensation

$0/yr

Location: Arden Hills, Minnesota
Level: senior
Posted: Sep 18, 2026

Summary from listing

Boston Scientific Cardiac Diagnostics is hiring a Senior Quality Engineer to lead quality initiatives, continuous improvement, regulatory compliance, and Corrective and Preventive Actions (CAPA) for medical device products and processes. The role partners with product development, suppliers, production, and commercial teams; investigates quality issues and nonconforming material; supports process validation and regulatory submissions; and mentors subject-matter experts. Candidates need a bachelor’s degree in engineering or a related discipline, at least five years of relevant quality engineering experience, and knowledge of medical device quality regulations, ISO 13485, risk management, and quality tools.

Required Skills

CAPA
Risk management
Quality tools
Data analysis
Regulatory submissions
Medical devices

Additional Information

Minimum Education: Bachelor’s degree in engineering or a related discipline
Required Previous Experiences: 5+ years of relevant quality engineering experience
CAPA experience, including root cause investigations and corrective action verification
Medical device industry experience
Preferred Qualifications: Experience with software and hardware development, manufacturing engineering, post-market complaints, risk management, supplier quality, and process engineering
Experience with Microsoft Office and Windchill PLM
2+ years of validation, statistical sampling, or root cause investigation experience
Familiarity with QMS documentation, including DHF, DMR, DHR, SOPs, WIs, and FMEAs
Problem-solving certification such as CQE or Six Sigma
Program or project management skills
Critical thinking, active listening, and time management
Ability to quickly learn new processes
Analytical and communication skills
Translation Company Name: Boston Scientific