The Quality Engineer is responsible for overseeing and manage the quality process (product development, supplier quality management, and post launch services support) and to ensure the quality of the product can satisfy specification, customer, and compliance requirement.
This position requires collaboration with Product Management, Supply Chain, International Team, Post Market Surveillance, Distribution Centersand Suppliers to develop and implement Quality improvement.

YOUR EDUCATION AND EXPERIENCE:

• Bachelor’s Degree in engineering field (mechanical, electrical, quality); or 2-4 years related experience and / or training / or equivalent combination of education and experience. Experience in a manufacturing environment preferred.
• Solid work experience on mechanical design / quality / engineering discipline
• Interfacing and collaborating with suppliers and customers
• Proven track record of quality improvements on products and processes

• Support new product development by providing quality expertise including qualification requirements based on applicable standards and regulatory requirements, developing testing protocols, and leading the product qualification process.
• Manage the product qualification process, ensuring adherence to product specifications and regulatory requirements. Support the qualification of private-label and retail items.
• Develop testing protocols based on product intended use and applicable regulatory requirements.
• Provide Quality Engineering input for the development of labeling and packaging specifications.
• Lead the risk assessment process, analyze complaint data and collaborate with the cross functional teams and suppliers in the investigation and mitigation of potential risks.
• Manage the supplier engineering change control process, collaborating with cross-functional teams to review and approve product changes, assess potential impacts, and ensure required documentation supports product safety and regulatory compliance.
• Assist cross-functional teams with product inquiries and external requests.
• Collaborate in the development of product records, providing input on product requirements, including testing protocols, labeling specifications, applicable standards, and regulatory requirements.
• Maintain key process indicators metrics, report findings to management, identify areas for improvement, and lead process enhancement initiatives.
• Investigate customer complaints, evaluate nonconforming products, and work with suppliers to determine root causes and implement corrective actions.
• Lead investigations of nonconforming materials, provide input on material disposition, and collaborate with suppliers to resolve quality issues.
• Participate in the CAPA process, evaluating internal process failures and implementing corrective actions.
• Provide weekly or regular updates on projects or outstanding issues to key stakeholders and provide clear action items and expectations.
• Develop and update work instructions, forms and procedures as needed for existing and new processes.