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.