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 we'll as Illumina product quality requirements for current operational objectives. Participates in continuous improvement activities of Illumina s suppliers, purchased parts and purchasing controls.
Responsibilities:
- Responsible in selection of new suppliers and partners for materials and services
- Responsible for leading 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
- Drives process, quality and product improvements through supplier 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 New Product Development, Manufacturing Operations, Supplier Development, and Product Quality
- Leads 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
- Leads supplier audits to drive process standardization and continuous improvement
- Identify opportunities for reduced inspection of purchased materials based on risk and quality performance
- Leads and facilitates 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
- Reviews non-conformance 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
- Ensures effective transfer of Suppliers from development to production activities
- Ability to provide training to other team members to ensure consistency and compliance to processes and procedures.
Requirements:
- Bachelors Degree with a minimum of 5 years of relevant experience
- Experience working in a regulated environment, in-vitro diagnostics preferred.
- Experience collaborating with cross-functional product development and operational teams
- Strong communication and negotiation skills
- 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
- 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 Agile, SAP or other PLM systems.
- Practical experience in FDA and ISO regulated environments is a plus
- Experience with statistical analysis packages such as JMP and Minitab is a plus
- Ability to travel domestically and internationally as needed. Estimate 25% of the time.
