Design Quality EngineerLocation: Mahwah, New Jersey
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:- Supporting design assurance for complex electromechanical pharmacy-automation products across new product development and sustaining engineering.
- Partnering with Engineering, Operations, Supplier Quality, and Regulatory teams to ensure design controls, risk management, verification and validation, and product changes meet applicable quality-system requirements.
- Providing quality-engineering support to NPD and sustaining projects for electromechanical hardware, automation systems, and associated subsystems.
- Guiding design-control deliverables, including design inputs and outputs, traceability, design reviews, verification/validation evidence, and design-history-file documentation.
- Facilitating risk-management activities using FMEA and related analyses; ensuring risk controls are implemented and verified.
- Reviewing engineering changes, nonconformances, complaints, CAPAs, and root-cause investigations for their impact on design quality.
- Partnering with Manufacturing and Supplier Quality on design transfer, process validation, and addressing supplier issues and product-realization activities.
- Supporting audit readiness and continuous improvement within an FDA-regulated, ISO 13485-aligned quality system.
Qualifications: - Bachelors in Engineering or related discipline, with relevant experience supporting hardware and electromechanical systems in a regulated environment.
- Proven experience in design quality, development quality, or quality engineering within regulated industries.
- Strong knowledge of design controls, risk management, FMEA, CAPA, root-cause analysis, and change control processes.
- Excellent technical documentation, review, and problem-solving skills.
- Ability to work collaboratively across functions to implement practical quality solutions.
- Experience in medical device or life sciences sectors.
- Familiarity with FDA Quality System Regulations and ISO 13485 standards.
- Hands-on experience with electromechanical systems, robotics, automation, or pharmacy technology.
- Exposure to design history files (DHF), verification & validation (V&V), manufacturing transfer, and supplier quality.
- 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