Sr Supplier Quality Engineer- Services/Channel Partners

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Position Summary:

This position is responsible for Supplier Quality activities thatimprove monitor and measure Illuminas compliance with the Quality System Regulations Illuminas Quality policies FDA regulations and ISO standards as well as Illumina product quality requirements for current operational objectives. Participates in continuous improvement activities of Illuminas suppliers purchased parts and purchasing controls.

Responsibilities:

• Responsible in qualification evaluation and monitoring activities of new suppliers and partners for Illumina products and outsourced services
• Collaborates with cross-functional subject matter experts to coach and represent partner and service supplier processes.
• Participate as a core/extended Quality team member of new product development and sustaining teams to assure processes are in place to design and release highly reliable and safe products
• Drives process quality and product improvements through supplier and partner development activities risk management identification and resolution of current and potential issues
• Responsible for updates to purchasing control procedures and processes as needed to stay compliant to quality system requirements and regulations. Provides Quality Assurance expertise and guidance for Service Supplier Partner Development and Product Quality
• Leads and facilitates Quality Investigations and CAPA/SCARs to resolve Quality issues with Service Supplier and Partner ensuring mitigations containment and corrective actions are implemented in a timely manner
• Leads supplier/partner audits to drive process standardization and continuous improvement including audit action timely resolution and closure.
• Support Global team initiatives including supplier/partner performance reviews corporate and site Quality Management Reviews and more.
• Supports regional initiatives associated with Service Supplier and Channel Partner process improvements and issue resolution.
• Make recommendations and drive programs to improve channel partners and service supplier performance
• Reviews non-conformance Quality Investigations Complaints and CAPA reports to identify actions needed to track and improve program health by site or globally.
• Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications
• Ability to provide training to other team members to ensure consistency and compliance to processes and procedures.

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.

Requirements:

• Experience collaborating with cross-functional product development and operational teams (Global HQ teams and local/regional teams)
• Strong QMS auditing (ISO 13485 ISO 9001 ISO 17025) experience
• Strong communication presentation and negotiation skills
• Working knowledge and experience with Quality Management Systems Project Management and Process Engineering methodologies and tools
• Experience with Non-conformance Handling Failure Investigation (CAPA/SCAR) and Risk Management (FMEA) activities.
• Demonstrated capability in successfully managing and leading change
• Practice identifying mitigating and resolving risks
• Ability to work effectively in a fast-paced dynamic environment with shifting and competing priorities
• Demonstrated experience in Supplier Quality and Management activities such as component qualification audits risk assessments.
• Experience with electronic product life cycle (PLM) systems such as EtQ SAP or other PLM systems.
• Practical experience in FDA and ISO regulated environments is a plus
• Experience with statistical analysis
• Ability to travel domestically and internationally as needed. Estimate 25% of the time.
• Ability to work PST hours to collaborate with teams in HQ in San Diego

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

Experience/Education:

• BS or equivalent in a technical discipline with 5 years of experience.
• MS in a technical discipline with 3 years of experience.
• PHD in a technical discipline with 1-3 years of experience.
• Experience working in a regulated environment in-vitro diagnostics preferred.

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 To learn more visit: 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.