Jobs

Description

Analyst, Product Surveillance II -(Sr Quality Specialist)

100% Onsite Burlington, MA 01803

Days/Hours: Mon – Friday 40 hours onsite-Daytime hours

Length of contract will be 8 to 12 months w/ possibility to extend or convert based on performance

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