As a Quality Engineer, you will play a crucial role in ensuring the highest level of quality standards are met during the Product Development Process (PDP) and throughout the lifecycle of our products.
This includes participating in the Quality Design and Development (QD&D) efforts during the initial design phase as well as providing ongoing support for sustaining manufacturing and product distribution.
Your focus will be on quality control, assurance, and continuous improvement, ensuring our products meet regulatory requirements and customer expectations.
Key Responsibilities :
Quality Design & Development :
Collaborate closely with cross-functional teams to support Quality Design and Development (QD&D) activities during the Product Development Process.
Ensure that all quality requirements are clearly defined, implemented, and adhered to throughout the design and development stages.
Product Development Process (PDP) :
Participate in the planning, execution, and monitoring of quality assurance measures during new product development. Conduct risk assessments, design validation, and verification activities to ensure the product meets design intent and regulatory standards.
Sustaining Manufacturing Support :
Provide ongoing quality support to sustaining manufacturing teams. Identify, investigate, and resolve quality issues in manufacturing processes to maintain consistent production standards.
Lead root cause analysis and implement corrective actions as needed.
Product Distribution & Post-Market Support :
Ensure quality assurance during product distribution and provide support for post-market surveillance activities. Monitor product performance and collaborate with field teams to address any quality concerns that arise in the market.
Compliance & Regulatory :
Ensure compliance with all applicable regulatory standards, including ISO, FDA, and other relevant industry regulations.
Prepare and maintain required documentation to support regulatory submissions and audits.
Continuous Improvement :
Drive continuous improvement initiatives in quality processes, systems, and procedures. Utilize data analysis and metrics to identify areas for improvement and implement effective solutions that enhance overall product quality and efficiency.
Collaboration & Communication :
Work closely with engineering, manufacturing, and supply chain teams to foster a culture of quality throughout the organization.
Communicate quality expectations clearly and collaborate on best practices to achieve common goals.
Qualifications :
- Bachelor’s degree in engineering, quality management, or a related field.
- Proven experience as a Quality Engineer, preferably in a manufacturing or product development environment.
- Strong knowledge of quality assurance methodologies, product development processes, and regulatory requirements.
- Proficient in risk management, root cause analysis, and corrective / preventive action processes.
- Excellent communication and problem-solving skills.
- Certification in quality management systems (e.g., Six Sigma, ASQ Certified Quality Engineer) is a plus.
Quality Engineer
The Quality Engineer is responsible for Quality both In-process and Final to the assigned program or area to ensure that the product is built in accordance with customer and division quality requirements. Reviews design drawings and changes, operation sheets, process procedures, test procedures, pro...
Quality Test Engineer
A company is looking for a Software Test Engineer to join their IT ERP Modernization team remotely. ...
Quality Engineer
Kamatics, a division of Kaman, is looking for a Quality Engineer to join our Quality team at our Bloomfield, CT facility. Bachelors degree in a related field such as Engineering or Quality preferred. This role will help the organization stay compliant to our quality, customer & regulatory bodies evo...
Quality Lead Validation Engineer
A company is looking for a Quality Lead/ Lead Validation Engineer to support the QISM group focused on IT Infrastructure and Clinical Operations. ...
Engineer I: 2025 Quality Engineering Development Program (onsite)
Bridging several diverse technical sub-disciplines - Supplier Quality, Manufacturing Quality, Program Quality, Materials Review and Lean Manufacturing/Six Sigma, participants get in-depth exposure to commercial and military engine technical problem solving, industry and regulatory compliance strateg...
Principal Quality Analyst Engineer
A company is looking for a Principal Quality Analyst Engineer for a long-term remote contract position. ...
Manufacturing Quality Engineer
Quality/Manufacturing Engineering experience. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing. You will oversee the op...
Quality Engineer
Broad knowledge of quality assurance engineering, electrical or mechanical engineering, or applied sciences. Our client is looking for a talented and dedicated Quality Engineer to join our exceptional team. If you possess excellent problem-solving skills and a strong commitment to quality, we want t...
Quality Engineer
AM - 3PM Our Client is Seeking a Quality Engineer with In-Process and Final Inspection processes, procedures and regulations. Reviews design drawings and changes, operation sheets, process procedures, test procedures, procurement documents, quality manuals, and inspection analyses to ensure that the...
Quality Engineer
As a Quality Engineer, you will play a crucial role in ensuring the highest level of quality standards are met during the Product Development Process (PDP) and throughout the lifecycle of our products. Work closely with engineering, manufacturing, and supply chain teams to foster a culture of qualit...