Senior Product Complaint & Quality Analyst

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

Job summary

Boston Scientific in Arden Hills, MN (Minneapolis area) seeks a Senior Product Analyst to enhance product quality across global markets. You will analyze customer complaints in the Neuromodulation Division's Complaint Management Center and collaborate with cross-functional partners to drive data-driven improvements that protect patients and improve outcomes.

This hybrid role requires regulatory knowledge, strong writing and presentation skills, and the ability to influence stakeholders.

Qualifications

• Bachelor's degree in a scientific, technical or related field.
• 5+ years in the medical device industry.
• Ability to adapt to changing priorities.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
• Working knowledge of FDA, ISO and other medical device regulations.

Responsibilities

• Serve as a positive influence on team culture by modeling high-quality work and collaborative approaches.
• Ensure regulatory compliance for medical device complaint handling and regulatory reporting.
• Review complaint communications and assess regulatory impact to patient safety and operations.
• Apply clinical knowledge to evaluate complaints and conduct investigations.
• Establish regulatory reportability decisions using hazard analyses and DFMEA.
• Code complaint events to support product performance records and coordinate with internal teams.
• Compose clear written communications detailing observations, investigations and corrective actions for physicians and end users.
• Support divisional initiatives and strategic priorities.
• Review peer work and identify process improvements.
• Utilize data analytics to identify risks and priorities.
• Provide concise communications and presentations to leadership.

Skills

Regulatory knowledge

Data analysis

Cross-functional collaboration

Effective communication

Clinical knowledge

Education

Bachelor’s degree in a scientific, technical or related discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Boston Scientific in Arden Hills, MN (Minneapolis area) seeks a Senior Product Analyst to enhance product quality across global markets. You will analyze customer complaints in the Neuromodulation Division's Complaint Management Center and collaborate with cross-functional partners to drive data-driven improvements that protect patients and improve outcomes.

This hybrid role requires regulatory knowledge, strong writing and presentation skills, and the ability to influence stakeholders.