Quality Process Specialist I

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

The Role:

- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Ensure that the organization's Quality Management System conforms to customer specifications/requirements, internal requirements/SOPs, ISO 13485, ISO 14971, and other relevant standards and regulatory/legal requirements.
- Ensure evaluation of, and reporting on, vendor quality systems.
- Oversee inspection (examination) of incoming materials, ensuring that they meet requirements.
- Manage the company's quality indicators, including monitoring, measurement, and review of internal processes including complaints, CAPAs, and training statistics.
- Support management review meetings by providing quality data.
- Support data collection for product recalls and field corrections.
- Stay current on standards, regulations/laws, and industry issues, applicable to medical device quality.
- A minimum of 3 years' of experience in Quality Systems
- A minimum of 1 year's experience in a medical device environment
- Experience with Software as a Medical Device
- Experience implementing quality policies in compliance with appropriate FDA and ISO 13485 processes
- Defining and leading processes across organizational boundaries
- Clear communications skills and persuasive negotiating strategies
- Creative approaches to quality requirements for business solutions in new geographies and environments
- Experience operating in a regulated medical products environment
- Excellent interpersonal skills, writing and presentation skills, in small and large group settings

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and 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.