Senior Quality Engineer

Job content

Why Us

Illumina are a global leader in genomics –an industry at the intersection of biology and technology. At the most fundamental level, we enable our customers to read and understand genetic variations. We strive to make our solutions increasingly simple, more accessible, and always reliable. As a result, discoveries that were unimaginable even a few years ago are now becoming routine and are making their way into patient treatment. Over the last few years, Illumina has experienced rapid expansion and this role or Senior Quality Engineer is supporting our continued growth plans. This role is based in our EMEA Head Office in Cambridge UK. You will work across EMEA and get involved in extensive truly exciting projects involving improving human health.

Why You

To be successful in this role you will have considerable experience as a Quality Engineer. Your experience will be in Quality/Regulatory Affairs in an in vitro diagnostics device, medical device required, regulated laboratory environment. Strong knowledge of ISO 13485:2016 is essential to be successful in this role.

Like you, we know the importance of your role and offer you a collaborative and supportive environment in which you are actively encouraged to continually develop your own skills and knowledge.

The Role

As our Senior Quality Engineer, you will be implementing process improvement, conducting critical reliability studies, validation reviews, addressing supplier quality and new product/process development issues in support of company production and quality objectives.

Responsibilities

• Assignments may include areas such as nonconformances, deviations, result/product release, control of documents, complaint handling, investigations, CAPA, material control, audits, etc.
• Monitor new and revised regulatory requirements in the area of Regulatory Compliance and translate information into area processes
• Participate as the subject matter expert during audits and/or inspections as needed
• Actively participate on Quality teams and cross-functional project teams as needed
• Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
• Identifies product and process improvements to reduce complaints and cost of poor quality
• Promotes global awareness and provides training to policy and procedures
• May be responsible for maintenance of local work instructions, SOPs and training of Quality Engineers and Associates.
• Provides recommendations for business process improvements as they are identified during the analysis, tracking, and trending of quality review inputs
• Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely fashion
• Other activities as assigned
  

Requirements

• Considerable experience in Quality/Regulatory Affairs in an in vitro diagnostics device, medical device required, regulated laboratory environment
• Strong knowledge of ISO standards such as ISO 15189, ISO 17025, ISO 13485
  

Preferred Background

• Typically requires considerable experience with a Bachelor’s degree; or some experience and a Master’s degree; or a PhD without experience; or equivalent work experience
  

What Can You Expect

With Illumina you can expect a highly competitive salary accompanied by a market leading benefits package. You will be part of the global leader in the Sequencing industry where you will find robust growth opportunities and career development within Illumina. For more information on

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.

INDHP

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.