Biomedical Quality Engineer II

POSITION SUMMARY

We are seeking a Biomedical Quality engineer to support product surveillance and quality activities within a medical device/healthcare environment. This position will focus on complaint handling, quality documentation, regulatory compliance, data analysis, and cross-functional communication.

The ideal candidate will have approximately 1+ years of experience in complaint handling, product surveillance, quality, or a closely related field. Candidates should be comfortable reviewing and documenting quality-related information, analyzing data, and working with cross-functional teams.

KEY RESPONSIBILITIES

• Perform activities related to product complaints, product surveillance, and quality processes.
• Review, investigate, and document complaint-related information in accordance with established procedures.
• Prepare clear, accurate, and compliant quality and medical documentation.
• Analyze quality and complaint data to identify trends, issues, and opportunities for improvement.
• Use Excel and/or Power BI to organize, analyze, and report data.
• Ensure activities and documentation comply with applicable regulatory requirements and quality standards.
• Communicate effectively with cross-functional teams, including Quality and other business functions.
• Identify potential process improvements and escalate quality concerns when appropriate.
• Participate in cross-functional projects and contribute to project goals.
• Work independently on assigned responsibilities while following established procedures and guidelines.
• Perform other related duties as assigned.

QUALIFICATIONS

• Bachelor's degree in Biomedical Engineering, Life Sciences, Engineering, or a related field, or an equivalent combination of education and relevant experience.
• Approximately 1-5 years of experience in complaint handling, product surveillance, quality, or a related quality function.
• Experience within the healthcare, medical device, pharmaceutical, or regulated industry preferred.
• Working knowledge of quality systems, regulatory requirements, and compliance.
• Strong written communication and medical/technical writing skills.
• Experience working with cross-functional teams.
• Strong analytical and problem-solving skills.
• Proficiency with Microsoft Excel; experience with Power BI is a plus.
• Strong attention to detail and ability to produce accurate, high-quality documentation.

Collaborative LLC is an equal opportunity employer.