Supplier Quality Engineer 2

Illumina; Alberta; On-site; CAD 70,000 - 90,000; Full time

Job summary

A global biotechnology company is seeking a Supplier Quality professional in Alberta, Canada, to ensure compliance with quality regulations and improve supplier performance. The ideal candidate will have a relevant degree, 2-5 years of experience, and skills in communication and collaboration. You'll work on quality assurance tasks, supplier audits, and drive improvements in product quality within a dynamic team-oriented environment.

Benefits

Inclusive work environment

Career development opportunities

Employee Resource Groups

Qualifications

• 2-5 years of relevant experience required.
• Experience with Contract Manufacturers/Suppliers is necessary.
• Familiarity with FDA regulatory environment preferred.

Responsibilities

• Support qualification of new Suppliers and Partners.
• Investigate root causes on material quality issues.
• Interface with multiple departments for quality improvements.

Skills

Detail orientation

Good communication

Collaboration skills

Education

Bachelor’s Degree in Engineering or Life Sciences

Tools

Microsoft tools

Enterprise Resource Planning (SAP)

Statistical analysis packages

Job description

Overview

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 involved in Supplier Quality activities that improve, monitor and measure Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.

Position Responsibilities

• Support qualification of new Suppliers and Partners for materials and services including risk assessments, audits and other supplier on-boarding activities.
• Provide support to investigation teams in determining root causes on material quality issues and initiate/ensure corrective and preventive action plans are developed and executed.
• Interface with Suppliers/CM (Contract Manufacturer), Engineering/ Manufacturing/ Quality Assurance/ Procurement departments to drive for quality improvements, specifically on incoming rejects, workmanship defects and primitive failures.
• Participate in Quality review activities with supplier/CM to identify improvement opportunities to meet quality expectation.
• Constantly review quality processes and suggests improvements that can be implemented to improve performances.
• Monitor to ensure supplier’s preventive and corrective actions are implemented and effective
• Participate with NPI team in selection of new suppliers
• 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

• Typically requires a Bachelor’s Degree in Engineering, Life Sciences, or related field with 2-5 years of relevant experience
• Experience in directly working with Contract Manufacturer/Suppliers
• Experience in conducting supplier audits.
• Developing basic knowledge of quality tools.
• Beginning to intermediate experience with Microsoft tools and spreadsheets, charting, graphing tools and presentation tools.
• May have experience with electronic production life (PLM), enterprise resource planning tools (SAP) and etc.
• May have experience with statistical analysis packages, e.g., JMP, Minitab.
• Must be detailed oriented, well organized and able to work independently and in teams.
• Good communication and collaboration skills
• Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485 strongly preferred.
• Experience in medical device/ pharmaceutical/ IVD is preferred.
• Ability to travel as needed, estimated around 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.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. 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 **************@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.