Energy Jobline AZ
Overview
Our client, a leading organization in the medical device industry, is seeking a dedicated and detail‑oriented Quality Engineer to join their team. The Quality Engineer 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. Location: Wayne, NJ | Pay Range: $65-$72/hr Responsibilities
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. Qualifications
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 . Strong knowledge of FDA 21 CFR 820, 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. Benefits
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 and . 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.
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Our client, a leading organization in the medical device industry, is seeking a dedicated and detail‑oriented Quality Engineer to join their team. The Quality Engineer 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. Location: Wayne, NJ | Pay Range: $65-$72/hr Responsibilities
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. Qualifications
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 . Strong knowledge of FDA 21 CFR 820, 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. Benefits
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 and . 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.
#J-18808-Ljbffr