Senior Quality Engineer
About The Position
The Senior Quality Engineer ensures that product complaint investigations, procedures, and related 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 according to corporate and unit policies and procedures. The position revises standard operating procedures and enforces laboratory-team compliance with equipment maintenance protocols, hazardous-material management, and biohazard and disposal management. It performs FTIR analysis to identify materials, including for foreign-matter complaint investigations; programs mechanical laboratory equipment such as Chatillon; conducts qualitative and quantitative analyses; and critically analyzes generated data. The role also provides audit support, including preparation, laboratory tours, and related activities. This is a 100% telecommuting role. The position reports to the company headquarters in Parsippany, New Jersey, and may be performed remotely or by telecommuting.
Requirements
- A Master’s degree in Engineering (any) or a related field of study and three years of work experience in the job offered or a related occupation; alternatively, a Bachelor’s degree in Engineering (any) or a related field of study and five years of such experience.
- Demonstrated experience with regulatory and international standards requirements, 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 related activities comply with FDA Quality System Regulations, ISO standards, and Medical Device Directives for Vigilance.
- Maintain good laboratory practices 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 standard operating procedures and enforce laboratory compliance with equipment maintenance protocols, hazardous-material management, and biohazard and disposal management.
- Perform FTIR analysis to identify materials, including during 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
