Senior Quality Engineer

embecta • Parsippany, NJ

7d • Remote

About The Position

The Senior Quality Engineer ensures product complaint investigations, procedures, and other activities comply with FDA Quality System Regulations, ISO standards, and Medical Device Directives for Vigilance. The role maintains good laboratory practices (GLP) consistent with product development objectives and regulatory requirements. It reviews customer complaint investigations for validity and ensures they are processed and investigated in accordance with corporate and unit policies and procedures.

The position revises SOPs and enforces compliance with equipment maintenance protocols, hazardous-material management, and biohazard and disposal management for the laboratory team. It performs FTIR analysis to identify materials, including in foreign matter complaint investigations; programs mechanical laboratory equipment such as Chatillon; performs qualitative and quantitative analysis; and critically analyzes generated data. The role also provides audit support, including preparation and laboratory tours.

This is a 100% telecommuting role reporting to company headquarters in Parsippany, New Jersey. The employee can work remotely or telecommute.

Requirements

• Master’s degree in any engineering discipline or a related field and three years of work experience in the job offered or a related occupation; alternatively, a bachelor’s degree in any engineering discipline or a related field and five years of such work experience.
• Demonstrated experience with regulatory and international standards, including 21 CFR 820, ISO 13485, and ISO 14971, to support quality engineering activities.
• Demonstrated experience using statistics for trend analysis and complaint data evaluation.
• Demonstrated experience with product failure modes.
• Demonstrated experience with quality engineering tools, including Root Cause Analysis, Design of Experiments, and Statistical Analysis.
• Demonstrated experience in quality audit management, including performing internal audits and representing the QMS during external notified body audits.
• Demonstrated experience with Corrective and Preventive Action (CAPA) to investigate root causes.
• Demonstrated experience with Engineering Design Change Management and DHF Management for medical devices.

Responsibilities

• Ensure product complaint investigations, procedures, and other activities comply with FDA Quality System Regulations, ISO standards, and Medical Device Directives for Vigilance.
• Maintain good laboratory practices (GLP) consistent with product development objectives and regulatory requirements.
• Review customer complaint investigations for validity and ensure they are processed and investigated in compliance with corporate and unit policies and procedures.
• Revise SOPs and enforce compliance with laboratory equipment maintenance protocols, hazardous-material management, and biohazard and disposal management.
• Perform FTIR analysis to identify materials, including as part of foreign matter complaint investigations.
• Program mechanical laboratory equipment such as Chatillon.
• Perform qualitative and quantitative analysis and critically analyze generated data.
• Provide audit support, including preparation, laboratory tours, and related activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior