What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
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. Participates in continuous improvement activities of Illumina’s 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.
Illumina believes that everyone has the ability to make an impact, and 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.
