Sr. QA Engineer

About This Role

The Quality Assurance Engineer collaborates with suppliers, development, and manufacturing teams to perform QA activities, support Design Transfer processes, and ensure quality standards are met throughout the product lifecycle.

Responsibilities

• 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
• Evaluate proposed changes to processes, equipment, or materials for validation impact
• Maintain and create product-specific risk files in accordance with ISO 14971
• Assist with calibration system maintenance
• Develop and revise procedures, work instructions, and test methods
• Document activities in compliance with medical standards and regulations
• Lead investigations into quality issues, complaints, and audit findings
• Support CAPA processes and promote QMS awareness and improvement initiatives
• Support management of new and approved suppliers
• Participate in internal and supplier audits
• Use root cause analysis and problem-solving tools to implement corrective actions
• Make data-driven decisions and propose solutions based on calculated risks

Requirements

• 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
• Strong proficiency in Microsoft Word and Excel
• Hands-on experience with manufacturing processes such as Electro-mechanical assembly, ESD controls, Cabling, Clean room operations, Labeling, Sterilization, Fiber optics
• Strong documentation skills for protocol and report generation and review
• Ability to analyze quality data and trends to identify improvement opportunities
• Experience executing process validation and test method validation / Gage R&R activities
• Experience with risk management activities per ISO 14971

Qualifications

• Bachelor’s degree in engineering or a related technical field
• 5–7 years of manufacturing quality experience within the medical device industry

Nice to Have

• Supplier management experience
• Proficiency with statistical software tools (e.g., Minitab)
• Prior start-up experience

Skills

* Required skills