27 days old

Compliance Quality Engineer

Kelly Services
Savannah, GA 31403
**Compliance Quality Engineer**


**Direct Hire**

**Savannah, GA**

Kelly Engineering has a direct hire opportunity for a **Compliance Quality Engineer** for a well-established medical device company. The Compliance Engineer will be responsible for managing the compliance requirements in development and maintenance of medical devices and accessories and design files documentation. Developing and implementing processes to ensure medical device projects/products are designed and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD/MDR and others as required. This role will also participate in the implementation of the companys quality system processes related to complaint handling, process validation, internal nonconformities, product development and supplier quality to provide engineering analysis and support in verification, validation and problem solving.

Email resume with Compliance Quality Engineer to for immediate consideration.

ESSENTIAL DUTIES AND RESPONSIBILITIES (may include but not limited to)

+ Achieves product and engineering compliance by ensuring product regulatory compliance in product development and product surveillance and completing documentation including Product Risk Management, compliance plans and approving product development documentation.

+ Prevents compliance issues by collaborating with engineering planning and design teams, reviewing design data, and developing compliance plans and requirements.

+ Partners with Regulatory Affairs in defining and execution of Regulatory Plans in product development projects.

+ Identifies and resolves product and engineering design issues by identifying short-term and long-range issues.

+ Researches and identifies applicable regulatory and industry compliance standards and codes.

+ Develops compliance plans by researching, analyzing, selecting, and applying compliance engineering concepts, approaches, techniques, and criteria.

+ Adapts and modifies compliance engineering options.

+ Develops and evaluates new compliance methodologies.

+ Organizes compliance plans by preparing researching and communicating applicable regulatory and international standards requirements.

+ Determines compliance by establishing compliance test standards, partnering with engineering in conducting and witnessing tests, performing diagnostic procedures, measuring performance, analyzing and evaluating findings, and performing forensic analysis and troubleshooting of failures.

+ Attains compliance by isolating and resolving compliance issues, recommending product and process changes, and initiating engineering change orders.


+ BS in industrial, mechanical, electrical, or environmental engineering or related field, required;

+ 2+ years relevant work experience in a manufacturing environment, preferably in compliance

+ 3+ years of experience in medical device industry regulatory compliance including experience in 21CFR, EU MDD, EU MDR and applicable ISO and International Standards.

Email resume with Compliance Quality Engineer to for immediate consideration.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2022-07-20 Expires: 2022-08-20

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Compliance Quality Engineer

Kelly Services
Savannah, GA 31403

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