Position Summary:
Interfaces with development and supplier engineering to provide materials and components for company product manufacturing. Communicates product specifications to suppliers and assesses supplier’s ability to meet engineering and quality requirements. Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
Position 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.
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:
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.
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:
Experience working in a regulated environment, in-vitro diagnostics preferred
Requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree in Engineering, Life Sciences, or related field.
Minimum 3 years specifically working as a Supplier Quality Engineer or in a closely related Supplier Relationship function. Demonstrated track record in component qualification, vendor audits, and supplier risk assessments.
Deep understanding of failure investigation (CAPA/SCAR), Risk Management (FMEA), First Article Inspection (FAI), and Mistake Proofing.
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 [email protected]. 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.
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