Quality Assurance Associate 2

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

• Perform in process and final release of medical device products from contract manufacturing organizations (CMOs) for E.U. and international markets including manufacturing, inspection, packaging and labeling batch records to ensure compliance. Generation of associated product release certificates, archiving of electronic and hard copy batch documentation.
• Ensure all appropriate CMO batch related documents are available, and all documentation issues including queries, deviations, change controls, out of specification investigations and CAPAs are closed to enable release of products in a timely manner. Communicates with cross functional team and CMOs to align on product release timelines and resolve batch record issues.
• Approve product certification documents for device and combination product components.
• Creates and updates quality agreements, processing new supplier requests and supplier change notifications. Assists with supplier quality related activities during transition of responsibilities from SQM to Device Quality.
• Perform batch record searches in support of complaint investigations.
• Support new product launches by assisting with the creating of a release process.
• Report quality system metrics relating to medical device product release activities as required
• Assess applicability of current standard operating procedures, device master records and product specifications.

• BS in Regulatory affairs or equivalent technical discipline required, and advanced degree preferred
• 3+ years of device and/or combination product experience within a medical device or biopharmaceutical organization
• Extensive knowledge of E.U., U.S. and international drugs and medical device regulations and standards including FDA 21 Code of Federal Regulations (CFRs) Part 820, 803, 211, 210, E.U. IVD and Medical device regulations, ISO 13485, ISO 14971.
• Experience with batch release process and excursions generated during GMP activities such as deviations, non-conformances (NCR), out of specification (OOS) investigations and CAPA
• Experience in leading, conducting, hosting medical device quality system audits (per ISO 13485 and 21 CFR 820) in addition to Medical device risk assessment per ISO 14971 and associated tools -FMEA, FMECA
• Experience in preparing and reviewing materials/deliverables for device submissions to Regulatory Authorities i.e. FDA, European Bodies
• Prior experience in a product release role
• Experience in providing quality support to on-market/commercialized products
• Experience in working with external suppliers &/or contract manufacturers

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with 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.

ICON, including subsidiaries, 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.

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.