Pride Health · 7 hours ago
Quality Engineer
Marlborough, MA
Contract
Hybrid
Lead/Staff
$65/hr - $70/hr
8+ years expPride Health is a healthcare staffing organization seeking a Staff Quality Engineer to support their medical client in Marlborough, MA. The role involves leading and maintaining quality systems, driving design control and risk management activities, and collaborating cross-functionally to ensure compliance with regulatory requirements.
Health CareHuman ResourcesInformation Technology
Hiring Manager
Ronit Tyagi
Responsibilities
Lead and maintain quality systems compliant with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR
Drive design control and risk management activities across the IVD product lifecycle
Review and approve design inputs/outputs, V&V documentation, and risk management files
Lead internal and external audits, CAPA, nonconformance investigations, and supplier qualification
Support regulatory submissions, complaints handling, and post-market surveillance activities
Collaborate cross-functionally to embed quality and regulatory requirements into product development
Analyze quality metrics and drive continuous improvement initiatives
Qualification
Required
Bachelor's degree required
8+ years' experience in medical devices/IVD with strong design control and risk management expertise
Deep knowledge of FDA, ISO, and IVDR requirements
Strong communication, problem-solving, and leadership skills
Preferred
ASQ and/or RAC certification preferred
Benefits
Comprehensive healthcare coverage (medical, dental, and vision plans)
Supplemental coverage (accident insurance, critical illness insurance, and hospital indemnity)
401(k)-retirement savings
Life & disability insurance
An employee assistance program
Legal support
Auto, home insurance
Pet insurance
Employee discounts with preferred vendors
Company
Pride Health
Pride Health is a staffing and recruiting company that provides account management and staffing solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Stephanie Barnes
Scheduling Lead PHC/OPWDD
Recent News
2025-11-06
Company data provided by crunchbase