Biomedical Engineer-Post Market Surveillance Speci

Senior Quality Specialist, Product Surveillance

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. The position collaborates closely with cross-functional teams to ensure adherence to applicable quality and regulatory requirements.

Key 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.

  Required Qualifications:

  • 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 with in 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:

    The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

    Pay Range: $30/hr to $38/hr

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