Quality Engineer

Quality Engineer
Location: Mahwah, New Jersey
About Our Client:
Our client has built a high-trust, people-first culture driven by real employee feedback and a commitment to innovation, collaboration, and performance. Known for fostering an environment where employees feel valued, supported, and empowered to grow, the organization continues to set itself apart as an employer of choice. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefront—offering driven individuals the opportunity to make a meaningful impact every day.
Key Responsibilities:

• Providing quality engineering support in quality assurance, control, and preventative activities within operations and other business functions.
• Developing and implementing methods and procedures for process control, process improvement, testing, and inspection to ensure that products are free of flaws and function as designed.
• Managing validation projects for new equipment and processes introduced to the plant.
• Developing, executing, and approving First Article Inspection (FAI) strategies.
• Creating and updating Standard Operating Procedures (SOPs) and Inspection plans through the change management system.
• Collaborating with the Manufacturing Engineering team, Sterility Assurance Teams, and Design Teams to land new equipment and set up processes for quality and compliance success by implementing appropriate, risk-based process controls and equipment maintenance measures.
• Advocating for and leading the execution of initiatives and projects aimed at enhancing quality performance within the business while ensuring compliance with regulations and standards.

Qualifications:

• Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• At least 1+ years of experience in the medical device or related industry.
• Strong knowledge of Quality Management Systems (QMS) and change management principles.
• Proven ability to interpret and develop validation protocols, SOPs, and inspection plans.
• Excellent communication skills and a keen eye for detail.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Demonstrated problem-solving and analytical skills.
• A proactive attitude and the ability to work effectively in a fast-paced, multi-site environment.
• Ability to build strong relationships and communicate confidently across teams.
• Experience with ISO 13485, GMP, GDP concepts.
• Familiarity with risk-based and statistical analysis methods.
• Prior experience developing or approving SOPs.
• Knowledge of landing new manufacturing equipment and validation processes.
• 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