Sr. Quality Operation Analyst

Supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for company products, services and processes. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.

Position Responsibilities:

• Applies core knowledge and understanding of area of specialization to provide solutions in creative and effective ways.
• Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify cause and suggest variations in approach.
• Works on assignments of diverse scope where information is limited and problem solving requires adaptation of existing techniques.
• Enhances internal and external working relationships and networks with senior partners within area of expertise.
• Adapts style to differing audiences and often advises others on difficult matters that require persuasion.
• Work is done independently and is reviewed at critical points.
• Uses evaluation, judgment, and interpretation to select best course of action.

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:

• Knowledge and practical experience of laws and QMS ministerial requirements.
• Proactive approach / able to appropriately demonstrate unique initiatives
• Business level English verbal communication skills and writings, especially Quality operation documentation and writings.
• Negotiation with internal / external stakeholders in difficult case
• Experience for IFU and/or Safety notification letter updates
• Native level Japanese verbal communication skills and writings.
• Basic PC Skills (Microsoft Excel, Word, PowerPoint, Access, Outlook)
• Minimum 5 year's work experience in Drug, Medical Device, and/or In Vitro Diagnostics industries.
• Minimum 3 year's work experience in Quality Control and/or Quality Assurance Organization under the Drug, Medical Device, and/or In Vitro Diagnostics industries.
• Work at 1st Class Medical Device MAH or equivalent, and/or IVD MAH
• Experience for acting as Quality Controller in 1st Class Medical Device MAH
• Experience for recall action under PMD Act
• Experience for Foreign Manufacturing site management

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

• Pharmacist license
• In Vitro Diagnostic reagent handling experience
• Electrical Instruments, Software as Medical Device experience
• Experience for Quality Controller (Kokunai Hinshitsu Sokatu Sekininsha)
• Experience for QMS Audit Experience (Internal/External)
• Experience for QMS Controller
• Experience for GVP Self inspection and/or equivalent audit experience
• Experience for working at Research and Development for Medical Device Software / reagent / instrument
• Experience for using Computerized Document Management System
• Have knowledge of Comprehensive Genome Profiles (GCP) sequencing
• Experience for Safety Controller (Anzen Kanri Sekinin Sya)

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 accommodations@illumina.com. 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. This role is not eligible for visa sponsorship.