"Alerted.org

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:** Wayne, NJ

**Pay Range:** $65-$72hr

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.

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

_ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.