Sr Design Quality Engineer

at  Illumina

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.
Senior Design Quality Engineer
Cambridge Chesterford - Onsite or Hub and Hybrid
We have a fantastic new opportunity for a Senior Design Quality Engineer to join our global quality team and actively participate in design control activities for both new product development and on-market design changes.
Illumina’s employee benefits are industry-leading and include flexible time off, private medical insurance, compassion and care time off, leisure travel insurance, pension, employee stock purchasing program, volunteer time off, and much more!
The Role
As Senior Design Quality Engineer you will be directly reporting to the Quality team in San Diego, USA you will be effectively collaborating with various functions in AMR and Europe.
In this cross functional quality role, you will actively participate in design control activities, including research and diagnostic applications. You will ensure product and process conformance to applicable safety and quality system regulations and standards (e.g. FDA (820), ISO 13485, ISO 14971, IVDR). You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure the company’s products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional project teams.

Key Responsibilities

• Provides Quality oversight to ensure Illumina’s products and processes are safe, effective, and meet customer performance needs throughout the product lifecycle
• Provides support for project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors
• Ensures products meet appropriate regulatory requirements (e.g. FDA, IVDR, ISO) in compliance with the quality management systems
• Leads product risk management activities
• Audits the quality and completeness of product Design History Files and/or Device Master Record
• Facilitates participation in the technical discussions and risk-based decision making utilizing knowledge of applicable technology
• Provides management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Utilizes quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)
• Other such duties that may be determined by Management

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.

Essential Qualifications Requirements

• Bachelor’s Degree Engineering and/or Science Degree with 5 years experience
• Master’s Degree Engineering and/or Science Degree with 3 years experience
• 4-6 years of related experience

Preferred Qualification required

• Technical expertise in products such as reagents, consumables, assays, instruments preferred
• Knowledge of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)
• Knowledge of FDA regulatory environment (CFR 820), 501k, ISO 14971, ISO 13485 and IVDR preferred
• Highly effective communication, facilitation, coaching, and negotiation skills
• Adaptable to fast-paced, dynamic work environment with shifting demands
• Must be detailed oriented, well organized and able to work independently and in teams

What can you expect
Our team members are bright, energetic and dedicated - they are the driving force behind our innovation and impact. To attract the best and brightest, we offer a competitive employee benefits program. We view it as a smart investment in our people, one that recognizes the tremendous value they bring to our business every day. At Illumina, we push boundaries. We think beyond the conventional. We dream big. With the energy of so many bright and accomplished people, the opportunities are endless.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunities 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

• Provides Quality oversight to ensure Illumina’s products and processes are safe, effective, and meet customer performance needs throughout the product lifecycle
• Provides support for project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors
• Ensures products meet appropriate regulatory requirements (e.g. FDA, IVDR, ISO) in compliance with the quality management systems
• Leads product risk management activities
• Audits the quality and completeness of product Design History Files and/or Device Master Record
• Facilitates participation in the technical discussions and risk-based decision making utilizing knowledge of applicable technology
• Provides management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Utilizes quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)
• Other such duties that may be determined by Managemen