Overview
Director, Quality Assurance – Medical Device Jobs in Village of Farmingdale, New York, USA at ICON plc
Location: Village of Farmingdale
Director, Quality Assurance – Cambridge, MA or Farmingdale, NY (Onsite Hybrid)
ICON plc is a leading healthcare intelligence and clinical research organization committed to innovation and excellence in clinical development.
We are seeking a Director, Quality Assurance (Medical Devices) to join our Central Laboratory team in Farmingdale, NY, or Cambridge, MA. Our laboratory hosts a kit building team that ensures seamless delivery of laboratory kits globally.
The successful candidate will oversee quality management within our ISO 13485-compliant IVD manufacturing, defining strategies for service improvement and collaborating with senior leadership to ensure operational efficiency.
Location: Onsite Hybrid (average 3 days/week)
Farmingdale, NY
Cambridge, MA
Key Responsibilities:
Lead, develop, and manage the QA team, establishing an effective management structure.
Develop and maintain an ISO 13485-compliant Quality Management System, including policies and SOPs.
Update the QMS regularly to reflect regulatory changes and industry best practices.
Support operational teams with issue resolution, process improvements, inspections, and audits.
Develop quality assurance policies to ensure IVD product quality throughout manufacturing.
Oversee product testing, inspection, and validation in collaboration with design controls.
Identify and manage quality risks, including CAPA processes.
Investigate and resolve quality issues and customer complaints.
Drive continuous improvement through quality metrics analysis.
Report on key quality indicators to management.
Contribute to global quality and compliance strategic planning.
Engage with clients as needed.
Travel up to 35% domestically and internationally.
Required Profile:
10+ years in medical device Quality Systems or QA roles.
Leadership experience managing teams.
Experience with medical device QMS, ISO 13485, IVDR, 21
CFR Part 820, or similar.
Knowledge of IVD GMP manufacturing and quality controls.
Strong communication skills.
Proficiency with Veeva and Track Wise.
Ability to work onsite 3 days/week in Farmingdale, NY, or Cambridge, MA.
#LI-TCT1 #LI-Hybrid
What ICON Offers:
Competitive salary, benefits focused on well-being and work-life balance, including annual leave, health insurance, retirement plans, and flexible benefits such as childcare vouchers, gym discounts, and more.
We value diversity and are committed to an inclusive, accessible environment. ICON provides equal employment opportunity and accommodations for candidates with disabilities.
If interested but unsure about meeting all requirements, apply anyway—your potential is what matters.
Salary Range: $ – $
Compensation includes potential bonuses, stock options, and benefits, determined by location, experience, and performance.
Current ICON employees can apply here.
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Title: Director, Quality Assurance – Medical Device
Company: ICON plc
Location: Village of Farmingdale, New York, USA
Category: Healthcare (Medical Science, Data Scientist), Quality Assurance – QA/QC
