Come join us and grow your career with CTG! CTG has worked with this international, Fortune 500 end-client for over 15 years! Apply with CTG for this exciting opportunity! CTG's premier client has a contract assignment for a Quality Engineer II. Type: Contract Job Title: Quality Engineer II Location: Kennebunk, ME candidates must be able to commute and work onsite in Kennebunk, ME Pay Rate: Based on experience Work Hours: M-F, 8am – 4:30pm Education: Associate or Bachelor’s degree in life sciences, engineering, or a related field. A successful candidate in this position will possess strong soft skills as well as: • Attention to detail • Excellent written and verbal communication skills • Ability to work independently and manage multiple priorities • Strong problem-solving and analytical skills Description: The Quality Engineer II will be responsible for the development, maintenance, and management of Medical Device Files (MDFs) in compliance with ISO 13485 standards. This includes performing change controls, creating and updating quality management procedures, managing records, and supporting internal audits to ensure compliance with the Quality Management System. Key Responsibilities: • Develop, review, maintain, and update medical device files in accordance with ISO 13485 standards. • Collaborate across functions (development, operations, engineering, and quality) to ensure all necessary documentation is gathered and properly recorded. • Address non-compliance issues identified during the creation of MDFs and work toward resolutions. • Initiate change controls and document change requests to update quality management procedures and processes. • Lead or support continuous improvement initiatives for quality management system processes. • Conduct internal audits to ensure adherence to the Quality Management System. • Other duties as required. Requirements: • 3+ years of experience in a manufacturing environment, preferably with medical devices. • Proficiency in Microsoft Office and Excel, with the ability to create detailed reports and manage data. • Ability to follow written procedures and maintain high levels of accuracy in documentation and record-keeping. • Detail-oriented with a focus on quality and accuracy. • Strong communication and interpersonal skills, with the ability to work cross-functionally with diverse teams. • Ability to work autonomously, managing multiple priorities and tasks effectively. • Experience working with ISO 13485 and other related regulations and standards. • Proven experience in the creation and management of Medical Device Files. • Internal auditing experience is preferred. • Project management skills are preferred. Additional Information: • No third-party resumes will be accepted. • Drug testing and/or other employment-related inquiries may be conducted. • CTG will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws. • All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third-party vendors). • CTG is an Equal Employment Opportunity employer. • CTG is an E-Verify Company. To be considered for this opportunity, please apply directly through our website by clicking the link below or email your Word version resume and salary expectations to Laura Dominguez at Laura.Dominguez@ctg.com. About CTG CTG, a Cegeka company, is at the forefront of digital transformation, providing IT and business solutions that accelerate project momentum and deliver desired value. Over nearly 60 years, we have earned a reputation as a faster and more reliable, results-driven partner. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG leverages the expertise of over 9,000 team members in 19 countries to provide innovative solutions. Together, we operate across the Americas, Europe, and India, working in close cooperation with over 3,000 clients in many of today's highest-growth industries. For more information, visit www.ctg.com. Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people define our culture. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work Certified™ company across many of our global operations. CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws. CTG is an Equal Opportunity and Affirmative Action Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. Our Affirmative Action program serves to promote occupational equality and diversity through good faith efforts. CTG is fully committed to promoting employment opportunities for members of protected classes.