PRODUCT SURVEILLANCE ANALYST II - AF2026
Techlink Systems
Job Description
Job Description
Job Description
Job Title: Analyst, Product Surveillance II
Location (On-site, Remote, or Hybrid?): Burlington, MA (onsite)
Contract Duration: Contract until 04/16/2027
Working hours: 8:00 AM - 5:00 PM
Total hours: 40
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
TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.
We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.
Company Description
TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\n\r\nWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.