Senior Product Quality & Compliance Analyst

Boston Scientific Gruppe; Arden Hills (MN); Hybrid; USD 72,000 - 136,000; Full time

Job summary

Boston Scientific is seeking a Senior Product Complaint Analyst to advance product quality and patient safety across global markets. You will evaluate customer complaints, prepare regulatory reports and support post-market surveillance within the Cardiac Diagnostics team.

You will ensure GMP/ISO compliance, analyze data to identify trends, and drive continuous improvements while collaborating with engineering and cross-functional teams.

Qualifications

• Bachelor’s or associate degree in a scientific/technical field with industry experience.
• Minimum 5 years in complaint handling, post-market surveillance or regulatory affairs.
• Proficiency with Word, Excel and PowerPoint; knowledge of FDA/ISO regulations.

Responsibilities

• Review complaints and regulatory assessments for reportability and impact on safety and quality.
• Investigate complaints with clinicians, field reps and lab data.
• Prepare MDRs/MDVs and other regulatory submissions per global requirements.
• Support CAPA, audits and quality-system processes.
• Communicate findings clearly to leadership and cross-functional teams.

Skills

Regulatory compliance understanding

Analytical problem solving

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in scientific/technical field

Associate’s degree in scientific/technical field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Boston Scientific is seeking a Senior Product Complaint Analyst to advance product quality and patient safety across global markets. You will evaluate customer complaints, prepare regulatory reports and support post-market surveillance within the Cardiac Diagnostics team.

You will ensure GMP/ISO compliance, analyze data to identify trends, and drive continuous improvements while collaborating with engineering and cross-functional teams.