NPD Quality Engineer at Norwood Medical LLC in Dayton, Ohio

Job Description:

We are seeking a highly motivated and experienced Quality Engineer to join our Quality New Product Development Engineering team!

As NPD 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 in collaboration with the NPD Engineers. You will collaborate with cross-functional teams, drive process improvements, and uphold our commitment to excellence in medical device manufacturing.

Position Responsibilities:
Develop and implement quality plan protocols and procedures to ensure compliance with regulatory requirements and industry standards (i.e., ISO 13485, FDA regulations).Collaborate with cross functional teams, including R&D, manufacturing, etc. to ensure quality considerations are integrated into new product development and manufacturing processes to meet our customers requirements.Perform product and process validations (with CNC machine processes) to ensure product performance and reliability.Monitor and analyze quality performance metrics, develop reports, and present findings to internal and external teams.Serve as the primary point of contact for quality related requirements and approvals during development and launch of new products.Oversee document control, including the creation, review, and management of technical specifications and customer submission packets.Maintain comprehensive records of quality related new product development activities.Provide training and guidance to employees on quality procedures and processes to ensure a culture of quality throughout the organization.