Sr. Quality Engineer- Production Support

Noah Medical•San Jose, CA

1d•Hybrid

About The Position

The Sr Quality Engineer – Production Support is a key member of the Product Quality organization, providing hands-on quality engineering support to manufacturing for both capital systems and disposable products. This role is production sustaining-facing and focused on execution, problem-solving, and operational rigor, ensuring quality is built, inspected, dispositioned, and released in compliance with regulatory and quality system requirements. The role partners closely with Manufacturing, Operations, Supply Chain, and Engineering to support day-to-day production, drive nonconformance resolution, and improve process capability and product quality through data and trending.

Requirements

BS degree in Engineering, Manufacturing, Mechanical, Electrical, Industrial, Life Sciences, or equivalent
6+ years of engineering experience in the medical device industry
4+ years in Manufacturing Quality, Quality Operations, or equivalent production-facing quality role
Hands-on experience supporting regulated manufacturing environments (FDA QSR / ISO 13485)
Strong experience with:
NCR management and MRB
Final product inspection and release
Manufacturing data trending and analysis
Experience with electro-mechanical assembly and/or disposable medical devices
Working knowledge of SPC, basic statistical tools, and defect trending
Experience with risk assessments (DFMEA, PFMEA, hazard analysis) as they relate to manufacturing issues
Familiarity with eQMS / ePLM systems, MRP systems, and standard office tools

Responsibilities

Provide real-time Quality Engineering support for Systems and Disposables production
Support Final Product Inspection, Acceptance, and Release activities
Ensure manufacturing output meets approved specifications, procedures, and quality requirements
Own and support Nonconformance Reports (NCRs) from identification through closure
Facilitate and participate in Material Review Board (MRB) activities, including disposition, documentation, and impact assessment
Ensure dispositions are compliant, risk-assessed, and aligned with design and validation requirements
Perform quality data analysis and trending (NCRs, defects, yields, inspection results)
Identify systemic issues and support escalation to CAPA when appropriate
Partner with Operations and Engineering to drive root cause analysis and corrective actions
Support and improve incoming, in-process, and final inspection methods and documentation
Assist with inspection/test method development and validation
Ensure inspection and release activities are executed in accordance with the QMS
Ensure manufacturing activities comply with FDA QSR, ISO 13485, and internal QMS requirements
Support audits, walkthroughs, and production readiness reviews
Provide hands-on guidance and training to manufacturing teams on quality processes and expectations
Partner closely with Manufacturing, Operations, Supply Chain, and Engineering to resolve issues efficiently
Support production scaling, factory improvements, and operational excellence initiatives
Represent Quality in daily production meetings and operational reviews
Other related duties

Benefits

Competitive Salary
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, Flexible Time Off + Sick Time
Paid parental leave
In-office snacks and beverages
In-office lunch stipend
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.