Kaye/Bassman International · 7 hours ago
Senior Quality Assurance Engineer – Medical Device
Greater Boston
Full-time
Onsite
Senior Level
5+ years expKaye/Bassman International is a leading innovator in medical device technology, specializing in cutting-edge solutions that advance patient care. They are seeking a Senior Quality Assurance Engineer to collaborate with suppliers and teams to perform QA activities and ensure quality standards throughout the product lifecycle.
ConsultingHuman Resources
Hiring Manager
Edward Canning
Responsibilities
Provide manufacturing quality engineering leadership to manufacturing and sustaining engineering
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
Assist in design transfer activities and maintain manufacturing documentation (DHRs, routers, BOMs, specifications)
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
Maintain and create product-specific risk files in accordance with ISO 14971
Develop and revise procedures, work instructions, and test methods
Support CAPA processes and promote QMS awareness and improvement initiatives
Participate in internal and supplier audits
Qualification
Required
Bachelor's degree in engineering or a related technical field
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
Preferred
Supplier management experience is preferred
Proficiency with statistical software tools (e.g., Minitab) is preferred
Company
Kaye/Bassman International
Kaye/Bassman International is a staffing and recruiting company that offers executive search and professional recruitment.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Jeff Kaye
Co-C.E.O.
Recent News
2024-11-16
Company data provided by crunchbase