Job Description

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 processes, external audits, Internal Audit Program and quality activities that measure, monitor, and improve Illumina\xe2\x80\x99s 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 meet 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.

Governance of site work instructions development and drive quality system documents review process at site.

Maintain and support quality system documents review process at site including system administration workflow and activities tracking.

Support and execute external audits as per schedule, including audit preparation activities, audit response preparation and timely audit response to external parties.

Support external audit daily operations including system administration workflow and metrics reporting.

Support Internal Audit Program and activities.

Support site CAPA process and activities.

Collaborate with stakeholders to ensure timely follow-up, completion and documentation of corrective actions.

Drive 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\xe2\x80\x99s degree in Science/Engineering background or equivalent.

Has basic knowledge in Microsoft Offices, i.e. Power Point, Excel, Word.

Has analytical skill, able to interpret information and data for routine operational needs.

Has attended ISO 13485:2016 or MDSAP awareness course.

Minimum 3-5 years\xe2\x80\x99 experience in Quality function.

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

Preferred Experience/Education/Skills:

3-5 years related manufacturing environment experience, preferred.

3-5 years\xe2\x80\x99 experience as QA within a regulated environment, 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.

Experience in medical device/pharmaceutical/IVD is preferred.

Has attended ISO 13485:2016 and MDSAP Internal Auditor related course is preferred.

Has good collaboration and auditing skill.

Has analytical skill, able to interpret information and data for routine operational needs is 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.

Has attended medical device/pharmaceutical/IVD related training or seminar is preferred.

Illumina believes that everyone has the ability to make an impact, and 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