Quality Engineer I, Post Market Surveillance - Remote

Overview

We are looking for a Quality Engineer I, for our facility in BD Peripheral Intervention. You will support coordination and management of Post Market Surveillance reports through the collection, analyses, review, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends.

In Short

• Support coordination and management of Post Market Surveillance reports.
• Collaborate with cross-functional team members to ensure compliance.
• Maintain compliance with global regulations.
• Work closely with different functions onsite and between BD sites.
• Generate periodic PMS related reports.
• Identify gaps and maintain PMS processes.
• Provide oversight in the analysis of PMS data.
• Work cross-functionally with Quality, Regulatory, Clinical Affairs, and Operations.
• Develop and maintain knowledge of support systems.
• Participate in projects aligning with BD Quality and regulatory submissions.

Requirements

• Minimum of a bachelor’s degree in Engineering or technical field.
• Proficient in Windows OS and Microsoft Office Suite.
• Strong interpersonal and problem-solving skills.
• Ability to create, review, and coordinate reports.
• Oral and written presentation skills.
• Ability to provide analysis within strict timeline requirements.
• Medical device experience preferred.
• Experience in technical writing and project management.
• Ability to develop and maintain dashboards using BI tools.

Benefits

• Supportive work environment for learning and growth.
• Culture that values opinions and contributions.
• Opportunities to innovate and improve continuously.
• Diversity and inclusion in the workplace.
• Flexible work-life balance.
• Commitment to ethical standards and integrity.
• Opportunity to make a difference in healthcare.
• Access to tools and information for decision-making.
• Collaborative team-oriented environment.
• Career advancement opportunities.