Principal Product Quality & Complaints Analyst

Boston Scientific Corporation; Arden Hills (MN); Hybride; USD 102 000 - 194 000; Plein temps

Avantages offerts par ce poste

Health benefits

Hybrid work arrangement

Résumé du poste

Boston Scientific Corporation in Arden Hills, MN is seeking a Principal Product Analyst to lead strategic initiatives that enhance product quality and performance globally. You will work with a cross-functional team to apply data-driven insights, identify risks, and drive decisions that improve health-care outcomes.

The role is hybrid, requiring in-office presence at least three days per week in Arden Hills.

Qualifications

• Bachelor's degree, preferably in a scientific, engineering or technical discipline.
• Minimum of 7 years' experience in the medical device, pharmaceutical or diagnostic device industry.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint and Visio.
• Working knowledge and practical application of FDA, ISO and MDR regulations.
• Demonstrated proficiency in project management.

Responsabilités

• Understand and ensure compliance with US and outside-US regulatory requirements for medical device complaint handling and regulatory reporting.
• Lead large, high-impact projects to improve post-market quality across divisions.
• Coordinate tasks and meetings to drive collaboration among multisite stakeholders.
• Present concise communications to senior leadership regarding deliverables and timelines.
• Influence change and align stakeholders with limited information.
• Provide audit support.
• Influence team culture with high-quality work and solution-oriented thinking.
• Use data and analytics to identify risk, opportunities and priorities.
• Support and implement new SOPs and work instructions to improve processes.
• Apply systems thinking to streamline quality systems and manage improvement plans.
• Identify and escalate risks and propose resolutions.
• Work independently across the organization.
• Demonstrate commitment to patient safety and product quality per Quality Policy.

Connaissances

Regulatory knowledge

Project management

Communication skills

Analytical thinking

Formation

Bachelor's degree in scientific/engineering/technical

Outils

Microsoft Office

SAS

Snowflake

Description du poste

Boston Scientific Corporation in Arden Hills, MN is seeking a Principal Product Analyst to lead strategic initiatives that enhance product quality and performance globally. You will work with a cross-functional team to apply data-driven insights, identify risks, and drive decisions that improve health-care outcomes.

The role is hybrid, requiring in-office presence at least three days per week in Arden Hills.