Position Summary:
This position is responsible for Supplier Quality activities that improve, monitor and measure Illumina’s compliance with the Quality System Regulations, Illumina’s Quality policies, FDA regulations and ISO standards as well as Illumina product quality requirements for current operational objectives. This role will participate in continuous improvement activities of Illumina’s suppliers, purchased parts and purchasing controls.
Position Responsibilities:
Select new suppliers and partners for material and services
Lead evaluation and qualification activities of Suppliers providing direct material/service.
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
Drive process, quality and product improvements through supplier development activities, risk management, identification and resolution of current and potential issues
Update purchasing control procedures and processes as needed to stay compliant to quality system requirements and regulations. Provides Quality Assurance expertise and guidance for New Product Development, Manufacturing Operations, Supplier Development, and Product Quality
Lead purchased material qualification/re-qualification activities such as performance qualification, process validation, first article inspection, measurement gage analysis and capability studies
Maintain goals and metrics for existing and new products, regularly reporting on the progress to reach departmental objectives
Lead supplier audits to drive process standardization and continuous improvement
Identify opportunities for reduced inspection of purchased materials based on risk and quality performance
Lead and facilitate failure investigations; ensuring mitigations and corrective actions are implemented in a timely manner
Make recommendations, and drive programs to improve purchased material and supplier performance
Review non-conformance and SCAR reports to identify actions needed to track and improve program health by site or globally.
Work with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications
Ensure effective transfer of Suppliers from development to production activities
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
Position Requirements:
Bachelor's Degree in Science or equivalent in a technical discipline with 5+ years of relevant experience
Experience in Supplier Quality and Management activities such as component qualification, audits, risk assessments
Experience with Quality, 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
Experience collaborating with cross-functional product development and operational teams
Strong communication and negotiation skills
Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities
Experience with electronic product life cycle (PLM) systems such as SAP
Practical experience in FDA and ISO regulated environments is a plus
Experience with statistical analysis packages such as JMP and Minitab is a plus
Experience working in a regulated environment, in-vitro diagnostics preferred
Ability to travel domestically and internationally as needed, estimated 25% of the time
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 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.