Analyst, Product Surveillance II

Analyst, Product Surveillance II#26-06279 Burlington, MA All On-site Job Description Analyst, Product Surveillance II -(Sr Quality Specialist)

• % Onsite 168 Middlesex Turnpike Burlington, MA 01803

Days/Hours:

Mon - Friday 40 hours onsite-Daytime hours Selected Candidates will start ASAP after screenings have cleared. Please see complete Job Description below for full Position Details Length of contract will be 8 to 12 months w/ possibility to extend or convert based on performance

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

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."