Director, Quality Assurance - Medical Device

Director, Quality Assurance - Cambridge, MA or Farmingdale, NY (Onsite Hybrid)

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 Director, Quality Assurance (Medical Devices) to join ICON’s Central Laboratory team in either Farmingdale, NY or Cambridge, MA. 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 Director, Quality Assurance will oversee all aspects of quality management within our ISO 13485-compliant IVD manufacturing entity. They will define and implement key strategies for improvement of services, while working with senior leadership from other Quality & Compliance functions to ensure efficient operations across the Quality & Compliance organization.

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

• Farmingdale, NY
• Cambridge, MA

What you will be doing:

• Lead, develop, grow and manage the Quality Assurance team, ensuring that an effective management structure is in place in the QA Team
• Develop, implement, and maintain an ISO 13485-compliant Quality Management System, QA activities, processes, and associated policies and SOPs, that meets regulatory obligations and supports business objectives
• Ensure that the QMS is periodically updated to reflect changes in regulations and industry best practices
• Provide input and support to operational teams on issue resolution, process improvements, inspections, and audits; as well as to regulatory teams to support regulatory submissions
• Develop and enforce quality assurance policies, procedures, and standards to ensure IVD product quality throughout the manufacturing process
• Collaborate with the head of design controls to oversee IVD product testing, inspection, and validation, to confirm that products meet specifications and regulatory requirements
• Identify and manage quality risks, including conducting risk assessments and implementing corrective and preventive actions (CAPA) as needed
• Oversee the investigation and resolution of quality issues, non-conformities, and customer complaints
• Drive continuous improvement initiatives by analyzing quality metrics, identifying trends, and implementing process improvements
• Provide periodic reports on defined key quality indicators to business operations and upper management
• Provide input into Global Quality & Compliance Leadership for strategic direction 
• Meet with clients and potential clients when necessary 
• Travel (up to 35%) domestic and/or international

Your profile:

• 10+ years of demonstrated practical medical device Quality Systems or Quality Assurance experience
• Leadership experience managing personnel
• Experience working within medical device quality management systems (QMS)
• Experience with ISO 13485, IVDR, and 21CFR Part 820 or other regulated industries
• Experience with IVD GMP manufacturing or product development and quality controls
• 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; Cambridge, MA

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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, 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.

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.

Salary range: $147,112.00-$183,890.00

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.

Are you a current ICON Employee? Please click here to apply