Analyst, Product Surveillance II-(Sr Quality Specialist)

Job title: Sr Quality Specialist

Location: Burlington MA USA 01803

Duration: 08 Months

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 ( 4 years) In life sciences or engineering.

or An equivalent combination of education and work experience

Experience Details

Maximum 2-4 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