QMS Compliance Specialist 2

Position Summary:

This position is responsible for Quality Management System (QMS) and Compliance activities, i.e. providing support to quality management system processes and quality activities that measure, monitor, and improve Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations, ISO standards as well as Illumina product quality for current operation and compliance objectives.

Position Responsibilities:

• Ensure the quality system meets customer, corporate, or internal requirements and any other related requirements within the Quality Management Systems.
• Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and third party audits.
• Maintain and support quality compliance training management, deploy and maintain new training activities at site level in alignment with site/corporate requirements.
• Maintain and support training compliance daily operations including system administration workflow and metrics reporting.
• Maintain and support quality system documents review process at site including system administration workflow and activities tracking.
• Support site Internal Audit Program and External Audits activities.
• Collaborate with stakeholders and peers to ensure timely follow-up, completion and documentation of quality investigation and corrective/preventive actions activities.
• Participate in certification/quality improvement related programs/projects.
• Work closely with cross-functional teams in overseeing and providing regulatory/compliance guidance on operational activities.
• Collaborate with others in developing training materials, coordinate training activities of company employees and/or deliver training program on Medical Device regulations.
• Drive new standard awareness at site.
• Support Quality Management Review at site, including action items follow up toward completion.
• Other such duties that may be determined by management.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:

• Bachelor’s Degree in Science/Engineering or an equivalent field of study
• Minimum 3-5 years’ experience in Quality function, preferably as QA in related manufacturing environment i.e. medical device/pharmaceutical/IVD
• Strong analytical skills, able to interpret information and data for routine operational needs
• Has attended ISO 13485:2016 or MDSAP awareness course. Attendance of ISO 13485:2016 and MDSAP internal auditor related course is highly advantageous
• Experience with training compliance management
• Good knowledge in Microsoft Office, i.e. Power Point, Excel, Word
• Strong collaboration and training management skills
• Basic knowledge of using Learning Management System is preferred
• Other experience in quality management systems/regulatory and/or compliance audits is preferred
• Good understanding of FDA Quality System Regulation (21CFR820) and ISO 13485 strongly preferred
• Has attended basic understanding of Risk Management for Medical Devices related course (ISO 14971:2012) is preferred
• Has attended current Good Manufacturing Practices (cGMP) related course is preferred

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.