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.

Additional Skills & Qualifications:

Must

•\tBachelor’s Degree in Engineering or related scientific discipline

•\t4+ years experience as a Quality Engineer in the medical device industry

•\tStrong communication, analytical and technical writing skills

•\tQuality Management Systems Experience

•\tAuditing (Internal and External)

•\tDocument Control

Plus

•\tExperience with new product development of medical devices

•\tWorking knowledge of US FDA and international regulatory requirements

•\tExperience with supplier quality management (approval, audit and incoming inspection)

•\tASQ certification preferred

•\tExperience working with statistical analysis software including Minitab®

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.