Biomedical Engineer-Post Market Surveillance Specialist

The Senior Quality Specialist, Product Surveillance is responsible for conducting quality-related activities that support the delivery of compliant, high-quality products, processes, services, and documentation. This role focuses on complaint handling, product surveillance, regulatory compliance, quality investigations, and continuous improvement initiatives.

Responsibilities

• Conduct product surveillance and quality assurance activities in accordance with established quality systems and regulatory requirements.
• Review, assess, and document product complaints while ensuring accurate and timely completion of records.
• Prepare and maintain high-quality technical and medical documentation related to quality events and investigations.
• Analyze quality and surveillance data to identify trends, risks, and opportunities for continuous improvement.
• Utilize reporting and analytical tools to support quality monitoring and business decision-making.
• Collaborate with cross-functional teams including quality, regulatory, operations, and engineering functions.
• Support compliance initiatives and ensure alignment with applicable global regulatory requirements.
• Investigate quality issues and develop practical, compliant solutions to complex problems.
• Participate in quality improvement projects and contribute subject matter expertise to project teams.
• Provide guidance and oversight on assigned quality activities while supporting organizational objectives.
• Represent the quality function on cross-functional initiatives as needed.
• Perform additional quality-related duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline, or an equivalent combination of education and experience.
• Minimum of 4 years of experience in quality assurance, product surveillance, complaint handling, or a related quality function.
• Experience with complaint handling and quality documentation.
• Strong medical writing and technical documentation skills.
• Knowledge of regulatory requirements and quality system compliance.
• Experience analyzing quality data and identifying trends.
• Proficiency with MS Excel and Power BI.
• Strong cross-functional communication and collaboration skills.
• Ability to manage multiple priorities with minimal supervision.
• Experience supporting continuous improvement initiatives.

Preferred Qualifications

• Experience within the healthcare, medical device, pharmaceutical, or life sciences industry.
• Background in product surveillance or post-market quality activities.
• Knowledge of global regulatory expectations and quality standards.
• Experience leading quality-related projects or initiatives.
• Experience mentoring junior quality professionals or contractors.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term disability insurance
• Short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time
• Paid vacation time
• Paid parental leave
• Paid holidays annually

Pay

$30/hr to $38/hr