Quality Engineer (Medical Device)

WaveCrest Staffing Group; New Jersey; On-site; USD 85,000 - 110,000; Full time

Job summary

WaveCrest Staffing Group is assisting a global medical device leader in Union County, NJ, to hire an experienced Quality Engineer. You will support product and process quality, develop inspection methods, investigate issues, and drive continuous improvement in collaboration with Manufacturing and Engineering to ensure regulatory and QMS compliance.

The role requires a Bachelor's degree in Engineering and 3+ years in medical device quality engineering, ISO 13485 experience, and proficiency with

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 3+ years of Quality Engineering experience in medical device or pharmaceutical manufacturing.
• Experience within an ISO 13485 Quality Management System.
• Proficiency with quality tools, including SPC, Gage R&R, and Process Capability.
• Experience conducting Root Cause Analysis and supporting CAPA investigations.
• Ability to read and interpret engineering drawings and dimensional measurement requirements.
• Strong analytical, problem-solving, organizational, and communication skills.

Responsibilities

• Develop and implement inspection, testing, and quality evaluation methods for products and manufacturing processes.
• Perform quality assurance testing and analyze results using statistical quality tools.
• Investigate nonconforming products, customer complaints, and quality issues using Root Cause Analysis and support CAPA activities.
• Create inspection plans, automated measurement programs, and maintain quality documentation.
• Collaborate with Manufacturing and Engineering to resolve day-to-day quality concerns and drive process improvements.
• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements.
• Manage multiple quality projects and perform other duties as assigned.

Skills

Quality engineering

Root Cause Analysis

Gage R&R

SPC

Process Capability

Education

Bachelor's degree in Engineering

Tools

SPC

Gage R&R

Process Capability

Job description

Our client, a global leader in the medical device industry, is looking for a experienced Quality Engineer to join their growing team. This is a great opportunity to work with a company that provides specialty medical technology solutions for some of the worlds most complex medical devices.

• Schedule: Onsite ~8a-5p M-F


• Type: Direct Hire


• Location: Union County, NJ

Position Summary

The Quality Engineer is responsible for supporting product and process quality by developing inspection methods, investigating quality issues, and driving continuous improvement initiatives. This role partners closely with Manufacturing and Engineering to ensure compliance with customer, regulatory, and quality system requirements.

Key Responsibilities

• Develop and implement inspection, testing, and quality evaluation methods for products and manufacturing processes.


• Perform quality assurance testing and analyze results using statistical quality tools.


• Investigate nonconforming products, customer complaints, and quality issues using Root Cause Analysis and support CAPA activities.


• Create inspection plans, automated measurement programs, and maintain quality documentation.


• Collaborate with Manufacturing and Engineering to resolve day-to-day quality concerns and drive process improvements.


• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements.


• Manage multiple quality projects and perform other duties as assigned.

Required Qualifications

• Bachelor's degree in Engineering or a related technical field.


• 3+ years of Quality Engineering experience in medical device (preferred) or pharmaceutical manufacturing.


• Experience working within an ISO 13485 Quality Management System.


• Proficiency with quality tools, including SPC, Gage R&R, and Process Capability.


• Experience conducting Root Cause Analysis and supporting CAPA investigations.


• Ability to read and interpret engineering drawings and dimensional measurement requirements.


• Strong analytical, problem-solving, organizational, and communication skills.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!