Junior Quality Engineer

Accountabilities

• Ensure exceptional service for internal customers
• Follow all procedures (SOPs) and documentation related to the Quality Management System to ensure compliance to all standards
• Support the development, revision and maintenance of procedures, documentation and standards, relevant to the Quality Management System (Incoming inspection, training, calibration, etc.) that ensure best practices and compliance
• Assist in the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, process performance, product performance, etc.
• Support complaint investigations and documentation activities under the guidance of senior quality personnel, according to the medical device regulations; FSA 21 CFR Part 820 and ISO 1348:2016, leading to process/product improvements
• Assist in implementing process improvements by using problem solving techniques, such as Problem-Solving Process (PSP), Variation Reduction (VRK) and continuous improvement techniques such as Value Stream Mapping (VSM), Transactional Process Improvement (TPI), and Lean/Six Sigma
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
• Lead and/or support CAPA investigations and related corrective and preventive actions
• Ensure training support and effectiveness for multiple functions throughout the organization
• Partner with functional teams to support maintenance of the QMS training program per regulatory requirements
• Assist in the reporting of effectiveness of the Quality Management System
• Provide support for internal and external audits and inspections
• Assist in ensuring department goals and objectives are reached
• Report the status of the Quality Management System and other related issues on a regular basis to the Sr. QA Engineer and/or Quality Assurance Manager
• Other duties as assigned by the Quality Assurance Manager

Job Requirements

• Bachelor's degree in Engineering or related field, or equivalent combined education and experience
• Minimum 1 year of experience as a Quality Engineer, or equivalent experience working with Quality Management Systems or with process/product improvements in a manufacturing environment
• Must reside within a commutable distance to Mahwah, NJ. This is not a hybrid or remote role.

Preferred Skills

• Prior work experience in a regulated medical device or pharmaceutical environment preferred
• Prior experience participating in regulatory audits a plus
• Prior experience managing complex data sets or statistical tools a plus
• Knowledge of quality systems and regulatory requirements applicable to medical devices (e.g., FDA QMSR/QSR, ISO 13485, MDR) preferred
• Ability to support investigations, CAPAs, nonconformances, complaints, and continuous improvement activities using structured problem-solving methodologies
• Strong analytical skills with the ability to review and interpret data, identify trends, and support data-driven decision making
• Proficiency in Microsoft Office applications; advanced Excel skills preferred
• Experience with ERP, quality management, or learning management systems preferred
• Ability to develop, review, and maintain quality documentation with a high level of accuracy and attention to detail
• Basic understanding of validation and qualification requirements for equipment, processes, and systems
• Strong communication and collaboration skills with the ability to work effectively in cross-functional teams
• Excellent organizational skills and ability to prioritize work in a fast-paced, regulated environment
• Demonstrated learning agility, initiative, and commitment to continuous improvement

Pay

$76,000 - $92,900