Fusion Life Sciences Technologies LLC · 8 hours ago
Quality Program Manager
Andover, MA
Contract
Onsite
Senior Level
$55/hr - $60/hr
7+ years expFusion Life Sciences Technologies LLC is seeking a proactive and strategic Quality Program Manager to lead key elements of their Quality Management System, focusing on the Corrective and Preventive Action program. The role involves driving cross-functional quality initiatives, ensuring regulatory compliance, and fostering a culture of continuous improvement across the organization.
Data ManagementLife SciencePharmaceuticalStaffing Agency
Hiring Manager
Vijaya Bandi
Responsibilities
Own and manage the CAPA Program, including administration, investigation quality, timeliness, effectiveness checks, and overall system health
Serve as the organizational CAPA SME, providing guidance on root cause analysis, risk assessment, and effective corrective/preventive actions
Continuously assess and improve QMS processes to ensure regulatory compliance, operational efficiency, and alignment with business goals
Lead the Internal Audit Program, including planning, execution, follow-up, and trending of audit outcomes
Prepare and analyze Quality Metrics and KPIs, providing data-driven insights for Management Review and executive reporting
Partner cross-functionally with Operations, R&D, Regulatory, and other stakeholders to resolve systemic issues and implement sustainable improvements
Support external audits and inspections, serving as a subject matter expert for CAPA and related QMS processes
Author and revise quality documentation (quality plans, procedures, work instructions, templates) to maintain compliance with evolving regulations
Champion a culture of quality and accountability through training, communication, and proactive engagement across all departments
Act as a quality liaison for key initiatives, ensuring integration of QMS principles into new projects and programs
Perform other tasks and duties as required
Qualification
Required
Bachelor's degree in an engineering or technical discipline, or another discipline demonstrating strong analytical, organizational, and communication skills. Equivalent combination of education and directly relevant experience will be considered
7+ years of experience in medical device or IVD industry, with focus on Quality Systems and CAPA management
Strong working knowledge of 21 CFR Part 820, ISO 13485, EU MDR, MDSAP requirements
Demonstrated success leading cross-functional quality initiatives and driving systemic improvements
Proven ability to interpret and apply regulatory requirements to drive improvement of quality system processes
Proficiency in problem-solving and root cause analysis methodologies (RCA, FMEA, 5-Why, etc.)
Excellent analytical, organizational, and communication skills
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Access)
Preferred
Certified Internal Auditor or experience leading internal and external audits
Advanced training or certification in root cause analysis, Six Sigma, or quality engineering methodologies
Demonstrated ability to develop and track meaningful quality metrics and KPIs
Strong interpersonal and influencing skills, with the ability to partner effectively across all levels of the organization
Company
Fusion Life Sciences Technologies LLC
Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive.
201-500 employees
H1B Sponsorship
Fusion Life Sciences Technologies LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (57)
2024 (95)
2023 (116)
2022 (135)
2021 (128)
2020 (133)
Funding
Current Stage
Growth StageLeadership Team
R
Rohith Kumar
Executive Partner
Company data provided by crunchbase