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Sr Design Quality Engineer

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Illumina

Nov 6

  • Job
    Full-time
    Senior Level
  • Science
    Engineering
  • Cambridge
  • Quick Apply

AI generated summary

  • You need a Bachelor's or Master's in Engineering/Science, 3-5 years of experience, quality analysis skills, FDA regulatory knowledge, strong communication, and adaptability in a dynamic environment.
  • You will ensure product safety and effectiveness, manage project quality, comply with regulations, perform risk management, audit design records, and utilize statistical analysis tools.

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
  • 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

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.

FAQs

What is the job title for this position?

The job title is Senior Design Quality Engineer.

Where is this position located?

The position is located in Cambridge Chesterford and offers onsite, hub, and hybrid working options.

What are the key responsibilities of a Senior Design Quality Engineer?

Key responsibilities include providing quality oversight, supporting project planning and development, ensuring regulatory compliance, leading risk management activities, and auditing quality documentation.

What qualifications are required for this role?

A Bachelor's Degree in Engineering and/or Science with 5 years of experience or a Master's Degree with 3 years of experience is required, along with 4-6 years of related experience.

What preferred qualifications should applicants have?

Preferred qualifications include technical expertise in products like reagents and instruments, knowledge of quality tools (e.g., SPC, Six Sigma), FDA and ISO regulations, and strong communication and organizational skills.

What kind of employee benefits does Illumina offer?

Illumina offers industry-leading benefits including flexible time off, private medical insurance, volunteer time off, and employee stock purchasing programs, among others.

What does the role emphasize in terms of team collaboration?

The role emphasizes collaboration across various functions in AMR (Americas) and Europe, ensuring effective communication and teamwork.

Are there opportunities for professional growth in this role?

Yes, Illumina encourages personal and professional development, allowing employees to be part of innovative and impactful projects.

Is there a specific regulatory knowledge required for this position?

Yes, candidates should have knowledge of FDA regulations (CFR 820), ISO 13485, ISO 14971, and IVDR.

What work environment can employees expect?

Employees can expect a fast-paced, dynamic work environment with shifting demands and opportunities for significant contributions to human health.

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Illumina

Unlocking the Power of the Genome

Science & Healthcare
Industry
5001-10,000
Employees
1998
Founded Year

Mission & Purpose

At Illumina, our goal is to apply innovative technologies and revolutionary assays to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. These studies will help make the realization of personalized medicine possible. With such rapid advances in technology taking place, it is mission critical to have solutions that are not only innovative, but flexible, scalable, and complete with industry-leading support and service. As a global company that places high value on collaborative interactions, rapid delivery of solutions, and prioritizing the needs of its customers, we strive to meet this challenge. Illumina’s innovative, array-based solutions for DNA, RNA, and protein analysis serve as tools for disease research, drug development, and the development of molecular tests in the clinic.