Sr Supplier Quality Engineer (Instruments/Plastics)

Illumina; Alberta; On-site; CAD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company dedicated to transforming human health through genomic technology. In this pivotal role, you will oversee Supplier Quality activities, ensuring compliance with quality regulations and standards. You will collaborate with cross-functional teams to enhance supplier performance and drive continuous improvement initiatives. Your expertise will be crucial in selecting and qualifying suppliers to deliver high-quality products. This position offers a unique opportunity to make a significant impact in a dynamic environment that values innovation and teamwork. If you are ready to contribute to life-changing discoveries, this is the role for you.

Qualifications

• 5+ years experience in Supplier Quality activities.
• Strong skills in communication and negotiation.
• Experience with FDA and ISO regulated environments.

Responsibilities

• Lead evaluation and qualification activities of suppliers.
• Drive process and product improvements through supplier development.
• Conduct supplier audits and manage non-conformance reports.

Skills

Supplier Quality activities

Cross-functional collaboration

Communication skills

Negotiation skills

Project Management

Process Engineering

Non-conformance Handling

Risk Management

Change Management

Statistical Analysis

Education

BS in a technical discipline

MS in a technical discipline

PhD in a technical discipline

Tools

Agile PLM

SAP

JMP

Minitab

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, ISO standards, and 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 the selection of new suppliers and partners for materials and services.
2. Lead evaluation and qualification activities of Suppliers providing direct material/service.
3. Participate 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. Drive process, quality, and product improvements through supplier development activities, risk management, and issue resolution.
5. Update purchasing control procedures and processes to stay compliant with quality system requirements and regulations. Provide Quality Assurance guidance for NPD, manufacturing, supplier development, and product quality.
6. Lead qualification/re-qualification activities for purchased materials, including validation, inspections, and capability studies.
7. Maintain goals and metrics for existing and new products, reporting progress regularly.
8. Lead supplier audits to drive process standardization and continuous improvement.
9. Identify opportunities to reduce inspection of purchased materials based on risk and performance.
10. Lead failure investigations, ensuring timely implementation of mitigations and corrective actions.
11. Recommend and drive programs to improve supplier performance.
12. Review non-conformance and CAPA reports to identify actions to improve program health.
13. Work with partners and suppliers to ensure global compliance to procedures and specifications.
14. Ensure effective transfer of suppliers from development to production.
15. Provide training to team members to ensure process and procedure compliance.

Minimum Requirements

• Experience collaborating with cross-functional product development and operational teams.
• Strong communication and negotiation skills.
• Experience with Quality, Project Management, and Process Engineering tools and methodologies.
• Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR), and Risk Management (FMEA).
• Proven ability to manage and lead change successfully.
• Skill in identifying, mitigating, and resolving risks.
• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.
• Experience in Supplier Quality activities such as component qualification, audits, and risk assessments.
• Experience with PLM systems like Agile, SAP, or similar.
• Practical experience in FDA and ISO regulated environments is a plus.
• Experience with statistical analysis tools like JMP and Minitab is a plus.
• Willingness to travel domestically and internationally (~25%).

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 is an equal opportunity employer committed to diversity and inclusion in the workplace.