Senior Manager, Quality Assurance

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

We have an incredible opportunity for a Senior Manager, Quality Assurance (Medical Devices) to join ICON’s Central Laboratory team. ICON's Central Laboratory hosts our homegrown kit building team which enables seamless delivery of laboratory kits to sites across the globe.

ICON is currently implementing a new ISO 13485 compliant Quality Management System. The Senior Manager, Quality Assurance will maintain the quality standards of the company’s products or services by ensuring adherence to company policies, regulatory guidance, and client specific requirements. They will assist the Director of Quality in managing all aspects of ICON’s medical device QMS across three US and one international location, including participation in Management Reviews and Quality Review Boards as needed.

Location: Onsite Hybrid (Onsite an average of 3 days per week)

• Farmingdale, New York
• Portland, Oregon
• Cambridge, Massachusetts

What you will be doing:

• Contribute to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and regulatory compliance of the products manufactured by the company
• Provide support for corrective and preventive system to ensure continued compliance to domestic and international regulatory regulations and documentation/records requirements
• Provide support for customer communication/feedback and complaints management systems to ensure complaints are properly received, investigated, and closed, and any follow-up actions (CAPAs) are taken
• Assist with generation and maintenance of supplier management documentation as well as support site-specific acceptance activities (incoming inspection / materials control, in-process quality controls, final inspection / batch record review and lot release)
• Support and conduct internal and external audits (including FDA and Notified Bodies) to ensure continued compliance to domestic and international regulatory regulations
• Support generation of General Safety and Performance Requirement (GSPR) checklists in support of EU Technical Dossiers
• Support development and management of UDI program for device labeling
• Work closely with Design Controls and Regulatory Affairs teams to ensure alignment of priorities and deliverables
• Support generation of Management Review presentation content as well as follow-up and closure of Management Review action items
• Travel (up to 35%) domestic and/or international

Your profile:

• 5+ years of demonstrated practical medical device Quality Systems or Quality Assurance experience
• Experience working within medical device quality management systems
• Experience with ISO 13485, IVDR, and 21CFR Part 820 or other regulated industries
• Experience with IVD GMP manufacturing or product development and quality controls
• Experience participating in and/or hosting ISO 13485 audits and FDA inspections
• Strong verbal and written communication skills
• Proficiency using Veeva and Trackwise for managing QMS activities
• Ability to work onsite an average of 3 days in one of the following locations: Farmingdale, NY; Portland, OR; Cambridge, MA

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   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.

Salary Range

Bonus, Com, Stock, Benefits & Disclaimer verbiage:

Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.   You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

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