Manager, Design Control

Manager, Design Control ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Quality Manager, DESIGN CONTROLS: On-Site in Cambridge, MA ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. The role This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The primary role of the Manager, Design Controls is to support the Quality and Scientific aspects of assay development/validation projects. Reporting to the Sr. Director, Design Controls, provide support for the ICON IVD Design Control process as follows: Drafting of Design Control Procedures, Policies, Forms, and tools. Managing records associated with all Design Control activities, including design history files (DHFs) and technical files (TFs) to ensure completeness and accuracy. Execution of strategic plans for IVD design control activities in alignment with company objectives and ensuring all IVD design control activities comply with applicable regulations and standards including assay development and validation and kit production. Maintaining a core understanding of the medical device regulatory process in collaboration with Regulatory Affairs and providing essential support during internal and external audits and inspections by supplying necessary documentation and addressing findings related to design control and regulatory compliance. Ensuring robust ISO14971 risk management processes are integrated into the design and development phases and risk management is performed Plan and conduct design phase review meetings Supporting IVD design control activities for new product development projects, ensuring timely and compliant progression through design phases. Coordinate with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and Manufacturing, to ensure cohesive and compliant product development. Working with Project Management team to drive project timelines to ensure projects are completed on time. Implement lessons learned from post-market surveillance and product performance to improve IVD design control practices. Promote a culture of quality and compliance within the organization through regular communication and training. To be successful in this role, you will have: Minimum of 7 years of experience in Quality Assurance, preferably with 2-3 years working with Design Controls within the medical device or clinical laboratory industry B.A. / M.A. in science related field preferred. Knowledge of FDA regulations, ISO 13485, IVDR, CLIA, and other relevant standards. Experience with Laboratory Developed Tests (LDTs) and understanding of their regulatory requirements. Experience working effectively with cross-functional teams. Proven leadership experience with the ability to manage and mentor team members. Strong interpersonal and communication skills, good laboratory and organizational skills, including the ability to work independently and efficiently. Ability to multitask, along with an orientation toward teamwork and leadership, and strong creative thinking and problem-solving skills. Benefits of Working in ICON: Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process to perform the essential functions of a position, please let us know through the form below. #LI-FL What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply To be considered for this role you will be redirected to our careers page & prompted to create a jobseeker account here. To start the process, click the Continue to Application or Login/Register button below.