G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing) · 7 hours ago
Quality Assurance Engineer
Hudson, MA
Full-time
Onsite
Senior Level
5+ years expG&H Staffing Companies is seeking a Senior Quality Assurance Engineer with experience in medical devices. The role involves collaborating with suppliers and teams to perform QA activities, ensuring quality standards are met throughout the product lifecycle.
Staffing & Recruiting
Responsibilities
The Quality Assurance (QA) Engineer is responsible for collaborating with suppliers, development teams, and manufacturing teams to perform QA activities. This includes, but is not limited to, supporting Design Transfer processes and ensuring quality standards are met throughout the product lifecycle
Support SCAR processes and manage nonconformances and rework evaluations for assigned suppliers
Handle supplier-related internal NCMRs, CAPAs, and complaint corrective actions
Provide sustaining support for process improvements and design changes transitioning into manufacturing
Investigate and disposition material nonconformances; participate in MRB meetings and follow up on supplier issues
Perform incoming inspection reviews and disposition of components and subsystems
Qualification
Required
Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
5–7 years of manufacturing quality experience within the medical device industry
Experience executing process validation and test method validation / Gage R&R activities
Experience with risk management activities per ISO 14971
Working knowledge of advanced statistical methods, including Hypothesis testing, Design of Experiments (DOE), ANOVA, R&R studies, Capability analysis, Tolerance interval analysis, Power and sample size determinations
Extensive working knowledge of 21 CFR Part 820, ISO 13485
Company
G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing)
Permanent and Temporary Staffing Solutions. Temp-Secure Staffing is a privately owned staffing agency located in Leominster, MA.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase