Sr QA Auditor

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’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 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.
- 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.
- Maintain and execute external audits as per schedule, including audit preparation activities, audit response preparation and timely audit response to external parties.
- Maintain and 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’s 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’ 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’ 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.