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We are seeking a highly skilled and experienced Quality Engineer to join our dedicated team at Norwood Medical. As a Quality Engineer in our medical device manufacturing environment, you will play a crucial role in ensuring the highest level of quality and compliance in our products and processes.

Job responsibilities include the following:

• Develop and implement quality plans protocols, and procedures to ensure compliance with regulatory requirements and industry standards (e.g. ISO 13485, FDA regulations).
• Perform product and process validations to ensure product performance and reliability
• Lead and participate in root cause analysis and corrective and preventative action (CAPA) processes to resolve quality issues and drive continuous improvement
• Collaborate with manufacturing teams to develop and implement quality control measure, including inspection plans and statistical process control techniques
• Collaborate with cross functional teams, including R&D, manufacturing, etc to ensure quality considerations are integrated into new product development and manufacturing processes
• Conduct internal audits to assess compliance with Norwood Medical's QMS and identify areas for improvement
• Monitor and analyze quality performance metrics, develop reports, and present findings to leadership teams
• Provide training and guidance to employees on quality procedures and processes to ensure a culture of quality throughout the organization

• Bachelor's degree in Engineering or related field
• Strong knowledge of quality engineering principles, methodolgies, and tools as well as regulatory requirements for medical devices (e.g. ISO 13485, FDA regulations)
• Solid understanding of statistical analysis and tools for quality improvement, such as SPC and root cause analysis
• Strong problem solving and analytical skills
• Excellent communication and interpersonal skills with the ability to collaborate effectively with cross functional teams
• Detail oriented with strong organizational skills and the ability to prioritize tasks in a fast pace environment

If you are a highly motivated Quality Engineer with a strong background in the medical device industry and a commitment to delivering high-quality products, we invite you to apply or the position of Quality Engineer at Norwood Medical. Join our team and contribute to the development and manufacturing of safe and effective medical devices that improve patients' lives!