Description:

　　Quality Engineer whose primary responsibility is to participate in the quality assurance of medical device products. This individual will work with Doctors and Engineers to develop creative, high quality devices. The Quality Engineer will define what methods and equipment should be used to measure quality standards and will also be responsible for partnering and training quality inspectors and technicians. This candidate will find defects and nonconformities, but also uncover their origin and develop creative solutions. In this role, the Quality Engineer is responsible for assisting in regulatory and quality assurance efforts. This individual ensures the company’s products conform to internal and external quality standards. He/she reports directly to the VP of Quality and will help lead the junior Quality Engineer.

　　Skills:

　　audit, document control, medical device, new product development, supplier quality, iso 13485, gmp, ppap, root cause analysis, quality management system

　　Top Skills Details:

　　audit,document control,medical device,new product development

　　Additional Skills & Qualifications:

　　Must • Bachelor’s Degree in Engineering or related scientific discipline • 4+ years experience as a Quality Engineer in the medical device industry • Strong communication, analytical and technical writing skills • Quality Management Systems Experience • Auditing (Internal and External) • Document Control Plus • Experience with new product development of medical devices • Working knowledge of US FDA and international regulatory requirements • Experience with supplier quality management (approval, audit and incoming inspection) • ASQ certification preferred • Experience working with statistical analysis software including Minitab®

　　Experience Level:

　　Intermediate Level

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.