Entegee · 1 day ago
Quality Assurance Engineer (Medical Devices)
Hudson, MA
Full-time
Onsite
Mid Level
$85K/yr - $135K/yr
4+ years expEntegee is seeking a Quality Assurance Engineer specializing in medical devices. The role involves supporting supplier quality management processes, conducting audits, and ensuring compliance with FDA regulations and international standards.
Information TechnologyStaffing Agency
Responsibilities
Support Supplier Corrective Action Request (SCAR) processes and manage supplier nonconformances and rework evaluations
Handle supplier-related internal NCMRs, CAPAs, and complaint-related corrective actions
Support onboarding and management of new and approved suppliers
Participate in supplier and internal audits
Execute and support process validation and test method validation activities (including Gage R&R)
Evaluate proposed changes to processes, equipment, or materials for validation impact
Create and maintain product-specific risk management files in accordance with ISO 14971
Document quality activities in compliance with FDA regulations and international standards
Lead investigations into quality issues, complaints, and audit findings
Support CAPA activities and promote continuous improvement within the Quality Management System (QMS)
Assist with maintenance of the calibration system
Develop, revise, and review procedures, work instructions, protocols, and test methods
Qualification
Required
Bachelor's Degree in Engineering
4+ years of manufacturing and/or quality experience in the medical device industry
Hands-on experience with: Process Validation and Test Method Validation, Gage R&R studies, Risk Management per ISO 14971
Extensive working knowledge of: 21 CFR Part 820, ISO 13485
Supplier management experience
Proficiency with statistical software (e.g., Minitab)
Working knowledge of advanced statistical methods, including: Hypothesis testing, Design of Experiments (DOE), ANOVA, Capability analysis, Tolerance interval analysis, Power and sample size determination
Hands-on experience with manufacturing processes such as: Electro-mechanical assembly, ESD controls, Cabling, Clean room operations, Labeling, Sterilization, Fiber optics
Strong documentation and technical writing skills (protocols and reports)
Benefits
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance
Company
Entegee
Entegee is a staffing and recruiting company providing contract engineers and technical specialists.
201-500 employees
H1B Sponsorship
Entegee 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 (5)
2024 (2)
2023 (1)
2022 (4)
2021 (8)
2020 (5)
Funding
Current Stage
Growth StageLeadership Team
Bob Bolster
Chief Operating Officer
Company data provided by crunchbase