Product Surveillance Analyst

Job Title: Analyst, Product Surveillance II
Location: Burlington, MA (onsite)
Contract Duration: Contract until 01/08/2027
Work Hours: 8:00 - 5:00

PURPOSE OF THE ROLE
Analyst, Product Surveillance II - (Sr Quality Specialist)

Main Purpose of the Role:
Conduct quality-related activities to deliver consistent, high-quality documents, services, products and processes. Ensure compliance with worldwide regulatory expectations/requirements.

Top Skills/Experience

• Experience with complaint handling, medical writing and cross functional communication
• Regulatory knowledge and compliance expertise
• Data analysis skills with ability to use tools such as excel and Power BI

Main Responsibilities

• Responsible for carrying out tasks related to core job responsibilities with little management oversight.
• May lead goals with cross-functional or broader scope.
• Provide solutions to a wide range of difficult problems.
• Solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
• Responsible for demonstration of core competencies and may be measured against some selected leadership competencies in conjunction with growth and development plan.
• Identify and elevate areas for continuous improvement.
• May perform other duties as assigned.
• May provide oversight to one or more QA professionals and/or contractors.
• Scope limited to one specific QA function but has general knowledge of other related disciplines.
• Interacts with employees, manager, and cross-functional peers.
• May represent team on cross-functional project teams with other functional leaders.
• Implements tactical activities related to assignment.
• Able to contribute functional skills and expertise broadly.
• Directly influences project direction and scope.
• May lead projects within function.
• Decisions may have short- and long-term impact.

Education

• Education Level Major/Field of Study or Equivalent
• Bachelor’s Degree (± 5+ years) In life sciences or engineering.
• or An equivalent combination of education and work experience

Experience Details

• Minimum 4 years In Quality or related field.
• Preferred Healthcare industry and experience in quality function.
• Utilize understanding of how their function supports the business and of technical/business competencies to drive continuous improvement results.
• Demonstrates proven track record utilizing core & technical competencies

• Developing product strategy with product management partners
• Shipped utilizing product control system
• Maintain software product management and agile product owner best practices
• Conduct product review with customer during product or process verification
• Solve business issues with software
• Effecting product development and launch
• Advise management on product development issues arising from product problems identified through technical support call with customers
• Develop new products or enhance existing product(s) or product
• Participate in pre-production testing and post-production support
• Reporting customer acceptance of product
• Consulting the customer product planning and analysis teams
• Analyze results of new product
• Help create detailed business requirements and technical system requirements
• Report for product file database analysis
• Performing routine inprocess testing to ensure product quality
• Conduct product review with customer during product or process verification
• Segregate and control non-conforming items
• Turn business needs into technical specifications that the software development team
• Perform product demonstrations to senior management
• Rotate and store all product