Senior Quality Specialist

Senior Quality Specialist

Alternate/Related Job Titles:
Senior Quality Assurance Specialist, Quality Compliance Specialist, Quality Systems Specialist, Medical Device Quality Specialist, Quality and Regulatory Specialist.

Location:

Burlington, MA

Onsite Flexibility:
Onsite

Contract Details (Contract roles only):

• Position Type:
  Contract
• Contract Duration: 7 Months
• Start:
  As Soon As Possible
• Pay Rate: $44.60/hr
• Shift: Monday – Friday, 8:00 AM – 5:00 PM

Job Summary:

The Senior Quality Specialist is responsible for performing quality-related activities to ensure consistent delivery of high-quality documents, services, products, and processes. This role supports regulatory compliance and quality standards across operations while contributing to continuous improvement initiatives and cross-functional collaboration
. The position works closely with internal stakeholders to ensure compliance with global regulatory expectations and to support quality assurance activities related to product and process oversight.

• Conduct quality-related activities to ensure compliance with regulatory and organizational quality standards.
• Handle complaint management activities and related documentation.
• Support medical writing and quality documentation processes.
• Collaborate with cross-functional teams to ensure quality compliance across projects and processes.
• Analyze quality and operational data using tools such as Excel and Power BI
  .
• Identify opportunities for process improvement and elevate quality issues when necessary.
• Provide solutions to complex quality challenges that align with organizational objectives.
• Participate in cross-functional project teams and represent quality functions when required.
• Provide oversight and guidance to QA professionals or contractors when applicable.
• Lead or support projects related to quality improvements and compliance initiatives.
• Implement tactical activities related to quality assurance assignments.

• Bachelor’s Degree in Life Sciences, Engineering, or a related field
  , or equivalent combination of education and experience.
• Minimum of 4 years of experience in quality assurance or a related field.
• Experience working in regulated environments, preferably within healthcare or life sciences.

• Experience in healthcare, pharmaceutical, or medical device industries.
• Experience leading cross-functional projects or supporting quality initiatives across teams.

• Complaint handling and quality documentation
• Regulatory knowledge and compliance expertise
• Data analysis using Excel or similar tools

• Power BI reporting and analytics
• Medical writing and technical documentation
• Cross-functional communication and collaboration
• Continuous improvement methodologies

• Quality systems and regulatory compliance monitoring
• Quality investigation and corrective action activities
• Quality project leadership and oversight
• Technical problem solving and process improvement
• Data-driven decision making and reporting
  
  Stakeholder engagement across quality and operational teams

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Global Healthcare Innovator

We're a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We're committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.

Join our team and:

• Work on cutting-edge projects
• Contribute to global healthcare advancements
• Experience diverse cultures and geographies
• Discover a rewarding career with a company that cares.

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-02201

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