The Judge Group · 1 day ago
Senior Quality Assurance Engineer
Marlborough, MA
Full-time
Onsite
Senior Level
5+ years expThe Judge Group is seeking a Quality Assurance (QA) Engineer to join their team onsite in Marlborough, MA. In this role, you will collaborate closely with suppliers, development teams, and manufacturing teams to ensure quality excellence throughout the product lifecycle, including supporting Design Transfer activities and maintaining compliance with medical device regulations.
E-LearningInformation TechnologyProfessional Services
Hiring Manager
Chris Melissen
Responsibilities
Support SCAR processes and manage supplier nonconformances and rework evaluations
Handle supplier-related internal NCMRs, CAPAs, and corrective actions for complaints
Provide sustaining support for process improvements and design changes entering manufacturing
Assist with design transfer and maintain key manufacturing documentation (DHRs, routers, BOMs, specs)
Investigate and disposition material nonconformances; participate in MRB meetings
Perform incoming inspection reviews and disposition components/subsystems
Assess proposed changes for validation impact (processes, equipment, materials)
Maintain and create product-specific risk files per ISO 14971
Support the calibration system
Develop and update procedures, work instructions, and test methods
Document all QA activities in compliance with medical device standards and regulations
Lead investigations into quality issues, complaints, and audit findings
Support CAPA processes and promote QMS improvements
Support onboarding and management of approved suppliers
Participate in internal and supplier audits
Apply root cause analysis and structured problem-solving tools
Make data‑driven decisions and propose risk‑based solutions
Qualification
Required
Bachelor's degree in engineering or related technical field
5–7 years of manufacturing quality experience within the medical device industry
Hands‑on experience with process validation, test method validation, Gage R&R
Experience with ISO 14971 risk management activities
Strong knowledge of advanced statistical methods: Hypothesis testing, DOE, ANOVA, R&R, capability analysis, tolerance interval analysis, power & sample size
Extensive knowledge of 21 CFR Part 820 and ISO 13485
Strong Microsoft Word & Excel skills
Hands‑on experience with manufacturing processes (electro‑mechanical assembly, ESD controls, clean room ops, cabling, labeling, sterilization, fiber optics)
Excellent documentation skills for protocols and reports
Ability to analyze quality data and identify improvement opportunities
Preferred
Supplier management experience (preferred)
Proficiency with statistical software (e.g., Minitab) preferred
Start-up experience is a plus
Company
The Judge Group
Results through the Power of Experience.
1001-5000 employees
H1B Sponsorship
The Judge Group 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
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
unknown1997-02-14IPO
Leadership Team
Charlton Monsanto
Executive Vice President of Integrated Services and Innovation
Recent News
Seattle TechFlash
2025-09-12
2025-08-05
The Judge Group
2025-05-07
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