Job Title: Manager, Design Control
About ICON plc
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
About 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.
Primary Responsibilities:
* Drafting of Design Control Procedures, Policies, Forms, and tools.
Key Skills and Qualifications:
* 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.
What ICON Can Offer You:
We offer 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.
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.