Sr. Design Quality EngineerLocation: Greater Atlanta Area
About Our Client:
Our client is a highly respected organization within the manufacturing industry, recognized for delivering innovative, high-quality solutions to a global customer base. They are committed to operational excellence and continuous improvement, leveraging advanced technologies to remain competitive and forward-thinking. With a collaborative, performance-driven culture, the company empowers employees to take ownership of their work while supporting professional growth and long-term career development. This is an excellent opportunity to join a stable, reputable organization that values integrity, quality, and its people.
Key Responsibilities:- Leading quality initiatives across the product lifecycle by serving as the Quality Assurance expert and owning Design Control, Document Control, and QA processes from concept to commercialization.
- Collaborating effectively with contract manufacturers and internal plants to seamlessly implement changes while maintaining the highest quality standards.
- Monitoring complaint trends proactively like a detective, identifying performance drift before it becomes a problem and executing swift corrective actions.
- Being the subject matter authority and the go-to resource for cross-functional teams in Engineering, Operations, and supplier management.
- Championing design control excellence by serving as the Quality Representative on project teams and ensuring design principles are woven into every product and process change, including new product development initiatives.
- Leading quality initiatives by providing QA leadership for project teams and the quality department.
- Mastering documentation by building, reviewing, and approving critical quality system documents including CAPAs and audit reports.
- Crafting compliance artifacts by creating and approving design history files, making sure every product decision is properly documented and defensible.
- Validating everything through developing, reviewing, and approving protocols for process and product validations, stability studies, and software validation documents.
- Assessing and mitigating risk by creating comprehensive risk assessments using FMEA, FMECA, and FTA methodologies.
Qualifications: - Bachelor's Degree in Engineering with 4+ years of Quality Engineering experience in a regulated environment or Masters Degree with 2+ years experience.
- Strong knowledge of FDA, MDSAP, PMDA, CFDA regulations, and experience working with international suppliers.
- Proficiency in statistical analysis, validation protocols, and risk management methodologies.
- Experience with electro-mechanical (capital system) products.
- Holding an ASQ certification is highly preferred.
- Membership in professional trade organizations dedicated to quality and regulatory standards.NO C2C CANDIDATES
Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company