Senior Quality Engineer

Overview

The Senior Quality Engineer ensures products meet internal & external quality standards and regulatory requirements throughout their lifecycle, from design to manufacturing, by implementing and maintaining quality systems, conducting audits, and resolving issues.

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, and system / services support.

Principal Responsibilities

• Supports the establishment, maintenance, and improvement of the company's Quality Management System (QMS) compliant with relevant regulations (ISO 9001, ISO 13485, FDA 21 CFR 820, etc.).
• Represents Quality be in core teams, cross-functional teams, providing compliance, development, manufacturing and post-marketed surveillance support.
• Leads or participates in internal and external audits and supports regulatory inspections. Performs gap analysis and resolves gaps with effective resolution to achieve audit readiness. Identifies quality strategies, rationale, technical pathways during external audits. Plans and executes suppliers' audits.
• Provides direct quality engineering support to manufacturing; conducts quality assurance tests, analyzes quality data, identifies trends, and generates quality reports to track metrics and KPIs.
• Identifies and implements effective process control systems to support the development, qualification, and manufacture of products to meet or exceed internal and external requirements.
• Participates in design control & risk analysis / management activities (e.g., dFMEA, pFMEA), and ensures the accuracy and integrity of Design History Files (DHFs), Device Master Records (DMRs) and Device History Records (DMRs).
• Verifies & validates manufacturing processes, equipment, and test methods to ensure they meet quality requirements and regulations and generates plans / protocols & reports (IQ, OQ, PQ) as needed.
• Investigates and resolves non-conformances, complaints, and other quality-related issues, and facilitates Material Review Board (MRB) reviews; leads / supports root cause investigations.
• Creates, reviews, and maintains quality documentation, including SOPs, CAPAs, test reports, and audit reports; initiates and / or approves change orders for documentation control per the QMS.
• Identifies training needs, performs & documents training, and verifies training effectiveness.
• Manages the company's Calibration Program to ensure that Inspection, Measuring & Test Equipment (IMTE) are in calibration and relevant data / records are maintained; supports environmental monitoring processes.
• Drives process quality monitoring and improvement using statistical tools / methods such as control plans, Cpk, Cp, SPC, DOE, process data analysis, Gage R&R, and DMAIC.
• Evaluates, qualifies and supports suppliers to ensure they meet quality requirements and regulations.
• Identifies areas for improvement in processes & products and implements changes to enhance quality, efficiency and reduce waste and costs.
• Represents Quality within cross-functional teams tasked with managing products through their lifecycle.
• Performs miscellaneous duties and projects as assigned and required.

Requirements

Training, Skills, Knowledge and / or Experience

Competencies

Education Requirements

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