QMS Compliance Specialist 2

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

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.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants.