Sr Supplier Quality Engineer- Services/Channel Partners

Illumina; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in genomic technology is seeking a Supplier Quality professional to enhance compliance with quality regulations and standards. The role involves evaluating suppliers, improving processes, and ensuring product quality. Ideal candidates will have strong experience in quality management systems and supplier quality activities, along with excellent communication skills. Join us to make a significant impact on global health.

Qualifications

• 5+ years of experience in Supplier Quality activities.
• Strong QMS auditing experience (ISO 13485, ISO 9001, ISO 17025).

Responsibilities

• Responsible for qualification, evaluation, and monitoring activities of new suppliers.
• Leads supplier/partner audits to drive process standardization.

Skills

Communication

Negotiation

Risk Management

Education

BS in a technical discipline

MS in a technical discipline

PhD in a technical discipline

Tools

EtQ

SAP

Job description

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:

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

Note: Listed responsibilities are essential but not exhaustive; responsibilities may change due to business needs.

Requirements:

1. Experience collaborating with cross-functional product development and operational teams (Global HQ and regional teams).
2. Strong QMS auditing experience (ISO 13485, ISO 9001, ISO 17025).
3. Strong communication, presentation, and negotiation skills.
4. Working knowledge of Quality Management Systems, Project Management, and Process Engineering tools and methodologies.
5. Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR), and Risk Management (FMEA).
6. Proven ability to manage and lead change successfully.
7. Skill in identifying, mitigating, and resolving risks.
8. Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.
9. Experience in Supplier Quality activities such as component qualification, audits, and risk assessments.
10. Experience with electronic product lifecycle systems like EtQ, SAP, or other PLM systems.
11. Practical experience in FDA and ISO regulated environments is a plus.
12. Experience with statistical analysis.
13. Ability to travel domestically and internationally (~25%).
14. Ability to work PST hours to collaborate with teams in San Diego.

All listed requirements are deemed essential; accommodations may be provided for additional tasks 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, preferably in in-vitro diagnostics.

At Illumina, we believe everyone can make an impact. We are an equal opportunity employer committed to diversity and inclusion in the workplace.