Quality Control Inspection

Manpower Group (USA); Wayne (NJ); On-site; USD 67,000 - 91,000; Full time

Job summary

Our client, a leading organization in the medical device industry, is seeking a dedicated and detail-oriented Quality Engineer to join their team in East Windsor, New Jersey. The role focuses on ensuring regulatory compliance and leading design control activities to deliver safe, effective medical devices.

You will develop test protocols, support cross-functional teams with failure investigations and CAPA, and maintain Design History Files with meticulous attention to documentation and

Qualifications

• Bachelor's degree in engineering, science, or related field is required.
• Minimum of 7 years' experience in quality or engineering in the medical device/pharma space.
• Experience with Class III disposable and/or electro-mechanical devices is preferred.
• Strong knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDD and EU MDR regulations.
• Excellent analytical, problem-solving, and communication skills; team collaboration ability.

Responsibilities

• Ensure design control activities including planning, risk management, verification/validation and design reviews.
• Develop and execute test protocols, reports, and data analyses for quality and compliance.
• Provide quality engineering support to cross-functional teams including CAPA and failure investigations.
• Maintain and update Design History Files with accurate documentation and regulatory compliance.

Skills

Analytical thinking

Communication skills

Problem-solving

Cross-functional collaboration

Education

Bachelor's degree in engineering, science, or related field

Job description

Our client, a leading organization in the medical device industry, is seeking a dedicated and detail-oriented Quality Engineer to join their team. As a Quality Engineer, you will be an integral part of the Product Development and Engineering department, supporting cross-functional teams to ensure the highest standards of quality and compliance. The ideal candidate will demonstrate strong analytical skills, excellent communication, and a proactive approach to problem-solving, aligning seamlessly with the organization’s commitment to excellence and innovation.

Job Title: Quality Engineer

Location: East Windsor, NJ

Pay Range:$38 per hour

What's the Job?

• Ensure product development and design change initiatives comply with industry regulations including ISO 13485, FDA 21 CFR Part 820, EU MDD, and EU MDR.
• Lead and participate in design control activities such as design planning, risk management, verification and validation, and design reviews.
• Develop and execute test protocols, reports, and data analysis to support product quality and compliance.
• Provide quality engineering support to cross-functional teams, including failure investigations and CAPA processes.
• Maintain and update Design History Files, ensuring documentation accuracy and regulatory compliance.

What's Needed?

• A bachelor’s degree in engineering, Science, or a related field.
• Minimum of 7 years’ experience in Quality or Engineering within the medical device or pharmaceutical industry.
• Experience with Class III disposable and/or electro-mechanical medical devices is preferred.
• Strong knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR regulations.
• Excellent analytical, problem-solving, and communication skills, with the ability to work effectively in a team environment.

What's in it for me?

• Opportunity to work on innovative medical devices that impact lives globally.
• Engagement with a dynamic and collaborative team environment.
• Professional growth through exposure to industry-leading quality standards and regulations.
• Supportive work environment that values diversity and inclusion.
• Chance to contribute to a company committed to excellence and continuous improvement.